Regulatory Affairs Managers

Salary: $65000-$75000 / Year

Amergis, formerly known as Maxim Healthcare Staffing, has served our clients and communities by connecting people to the work that matters since 1988. We provide meaningful opportunities to our extensive network of healthcare and school-based professionals, ready to work in any hospital, government facility, or school. Through partnership and innovation, Amergis creates unmatched staffing experiences to deliver the best workforce solutions.

The Compliance Manager leads and supports the Sunburst Credentialing Specialists to ensure all contingent workers are compliant with Customers, Sunburst and industry requirements.

Essential Duties and Responsibilities:

+ Collaborates with Credentialing Specialists and Program Management team to enforce all compliance requirements for all active accounts

+ Partners with Talent Acquisition and Program Management team to identify, screen and hire all Credentialing Specialist roles

+ Supports Credentialing Specialists with proper training and continuing education necessary to perform role

+ Ensures the Credentialing Specialists are tracking and monitoring all pre-assignment and contract specific requirements

+ Supports Credentialing Specialists to ensure activities and plan is being executed in order to obtain updated credentials from suppliers for contractors on assignment, prior to expiration

+ Executes audit plan to evaluate that active contractors are fully credentialed properly, as a further quality assurance measurement

+ Collaborates with customers, suppliers, and Program Management team to ensure optimal compliance related reporting is adopted and utilized

+ Partners with the Implementation and Program Management team during discovery to review customer specific and state specific credentialing requirements

+ Establishes and maintains updated credentialing requirements for all Sunburst customers

+ Conducts annual compliance review and refresh per customer

+ Adheres to evolving healthcare mandates, policies and requirements set forth by industry, customer, and State & Federal guidelines

+ Displays strong organizational and time management skills to efficiently support the Credentialing Specialists and Program Management team

+ Establishes and maintains effective channels of communication within the division, as well as with customers and suppliers

+ Provides excellent customer service to all customers, suppliers, and Internal Team Members

+ Performs other duties as assigned

Minimum Requirements:

+ High school diploma or equivalent; Undergraduate degree preferred

+ Healthcare terminology experience preferred

+ One year of work experience within a team environment preferred

+ Excellent verbal and written communication skills; proficiency in the English language is required

+ Proficiency with computers, including Microsoft Office

+ Ability to work independently and multitask effectively, while maintaining attention to detail

+ Ability to effectively elicit from and provide information to all Team Members, clients and suppliers using strong communication skills

At Amergis, we firmly believe that our employees are the heartbeat of our organization and we are happy to offer the following benefits:

Medical/Prescription, Dental, Vision, Health Advocacy (company paid if enrolled Medical), Health Advocate Employee Assistance Program, Health Savings Account , 401(k), 401(k) Company Match, Profit Sharing, Short Term Disability, Long Term Disability, Primary Caregiver Leave, Parental Leave, Life and Basic Accidental Death and Dismemberment Insurance, Voluntary Life and Accidental Death and Dismemberment Insurance, Hospital Expense Protection Plan, Critical Illness Insurance, Accident Insurance, Dependent Care Flexible Spending Account, Home and Auto Insurance, Pet Insurance, MilkStork, Transportation Benefit, Educational Assistance Program, College Partnership Program, Paid Time Off/Company Holidays

*Benefit eligibility is dependent on employment status.

Amergis is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

This posting will remain active on job boards for 5 days from date of posting unless there is a good faith basis to extend the posting date.

Please note that this pay range represents a good faith estimate of the compensation that will be offered for this position based on the circumstances. The actual pay offered to a successful candidate will take into account a wide range of factors, including but not limited to location, experience, and other variable factors.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

**Summary:**

Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

**Primary responsibilities:**

+ Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products

+ Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.

+ Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

+ Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.

+ Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

+ Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

+ Writes documents with complex scientific information for regulatory submissions.

+ May supervise staff

+ May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

**Additional responsibilities:**

+ Represent R&D Compliance in professional and industry organizations.

**Knowledge, skills, & abilities:**

Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

**Requirements:**

Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation. Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Pay scale of $90,000.00-$180,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

**Occupational Demands:**

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.**

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

**Req ID:** 527460

**Type:** Regular Full-Time

**Job Category:** Regulatory Affairs

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

**Summary:**

Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

**Primary responsibilities:**

+ Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products

+ Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.

+ Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

+ Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.

+ Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

+ Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

+ Writes documents with complex scientific information for regulatory submissions.

+ May supervise staff

+ May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

**Additional responsibilities:**

+ Represent R&D Compliance in professional and industry organizations.

**Knowledge, skills, & abilities:**

Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

**Requirements:**

Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation. Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Pay scale of $90,000.00-$180,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

**Occupational Demands:**

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.**

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

**Req ID:** 527460

**Type:** Regular Full-Time

**Job Category:** Regulatory Affairs

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

**Summary:**

Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

**Primary responsibilities:**

+ Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products

+ Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.

+ Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

+ Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.

+ Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

+ Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

+ Writes documents with complex scientific information for regulatory submissions.

+ May supervise staff

+ May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

**Additional responsibilities:**

+ Represent R&D Compliance in professional and industry organizations.

**Knowledge, skills, & abilities:**

Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

**Requirements:**

Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation. Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Pay scale of $90,000.00-$180,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

**Occupational Demands:**

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.**

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

**Req ID:** 527460

**Type:** Regular Full-Time

**Job Category:** Regulatory Affairs

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

**Summary:**

Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

**Primary responsibilities:**

+ Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products

+ Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.

+ Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

+ Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.

+ Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

+ Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

+ Writes documents with complex scientific information for regulatory submissions.

+ May supervise staff

+ May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

**Additional responsibilities:**

+ Represent R&D Compliance in professional and industry organizations.

**Knowledge, skills, & abilities:**

Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

**Requirements:**

Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation. Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Pay scale of $90,000.00-$180,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

**Occupational Demands:**

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.**

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

**Req ID:** 527460

**Type:** Regular Full-Time

**Job Category:** Regulatory Affairs

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

**Summary:**

Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

**Primary responsibilities:**

+ Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products

+ Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.

+ Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

+ Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.

+ Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

+ Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

+ Writes documents with complex scientific information for regulatory submissions.

+ May supervise staff

+ May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

**Additional responsibilities:**

+ Represent R&D Compliance in professional and industry organizations.

**Knowledge, skills, & abilities:**

Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

**Requirements:**

Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation. Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Pay scale of $90,000.00-$180,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

**Occupational Demands:**

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.**

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

**Req ID:** 527460

**Type:** Regular Full-Time

**Job Category:** Regulatory Affairs

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

**Summary:**

Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has interactions with regulatory authorities to expedite approvals. Participate in the development of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical guidelines to assure execution of regulatory strategies and requirements. This is a fully remote role.

**Primary responsibilities:**

+ Develops and implements worldwide regulatory strategies for projects and issues affecting development of new products or medical devices or new indications for existing products

+ Provides regulatory expertise to Research and Development to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies.

+ Utilizes scientific training when interfacing with Management of technical areas and project teams to guide the scope of experimentation and the selection of data needed to support regulatory submissions.

+ Interacts with regulatory authorities regarding programs and initiatives that significantly impact the business.

+ Advises Management on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans.

+ Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory requirements.

+ Writes documents with complex scientific information for regulatory submissions.

+ May supervise staff

+ May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of needed updates/changes

**Additional responsibilities:**

+ Represent R&D Compliance in professional and industry organizations.

**Knowledge, skills, & abilities:**

Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral and written communication skills. Critical thinking and problem solving skills. Demonstrated project management skills. Ability to interact with regulatory officials. Ability to evaluate complex issues and meet deadlines to ensure compliance, as well as business timelines to accomplish company objectives. Ability to work within a global team framework and multi-cultural environment.

**Requirements:**

Bachelor's Degree in a related scientific discipline plus 8 or more years of experience in positions of increasing responsibility within Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write comprehensive scientific information for use in regulatory submissions. Ability to manage multiple complex projects and timelines in a matrix team environment. Demonstrated interpersonal skills including negotiation. Ability to execute regulatory strategies through to commercialization/life cycle. Prior experience in bridging several scientific disciplines. Leadership skills within a matrix driven organization.

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

Pay scale of $90,000.00-$180,000.00 per year, depending on training, education and experience. This position is eligible to participate in up to 15% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years — we’re growing, and you can grow with us!

**Occupational Demands:**

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Frequently interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Ability to apply abstract principles to solve complex conceptual issues.

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

**Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law.** **We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.**

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

**Req ID:** 527460

**Type:** Regular Full-Time

**Job Category:** Regulatory Affairs

**Alternate Locations:** Fort Wayne, IN (Indiana); Work from Home

**Work Arrangement:**

Remote : Work at home employee

**Relocation assistance:** is not available for this opportunity.

**Requisition #:** 74829

**The Role at a Glance**

We are excited to be hiring a **Manager, Compliance testing team** role in our Retirement Plan Services business line in our Fort Wayne office or remote. In this role you will manage a team and processes for their assigned client service area(s) of responsibility. You will ensure good customer relations are maintained, and more complex customer inquiries and concerns are resolved fairly and effectively.

**What you'll be doing**

• Ensures that top talent is hired and retained

• Manages a team and processes for their assigned area(s)

• Manages the processes and administration of customer inquiries, ensuring accurate, fair and efficient management

• Provides more complex guidance to client service team members on customer inquiries and/or concerns

• Reviews and resolves more complex escalated issues and concerns, escalates issues as needed to management

• Forecasts telephone volumes and short and long-term staffing requirements

• Designs and implements training plans based on assessment of team needs

• Monitors and controls expenses within defined budget limits

**What we’re looking for**

_Must-haves:_

5+ Years of experience in Client Services that directly aligns with the specific responsibilities for this position

2+ years of managerial, supervisory, and/or demonstrated leadership experience

4 Year/Bachelor's degree or equivalent work experience (4 years of experience in lieu of Bachelor's)

Working knowledge of retirement plan administration, nondiscrimination testing and 5500’s

_Nice-to-haves:_

ASPPA QKA

Working knowledge of FT Williams and ASC

**Application Deadline**

Applications for this position will be accepted through August 8th, 2025, subject to earlier closure due to applicant volume

**What’s it like to work here?**

At Lincoln Financial, we love what we do. We make meaningful contributions each and every day to empower our customers to take charge of their lives. Working alongside dedicated and talented colleagues, we build fulfilling careers and stronger communities through a company that values our unique perspectives, insights and contributions and invests in programs that empower each of us to take charge of our own future.

**What’s in it for you:**

+ Clearly defined career tracks and job levels, along with associated behaviors for each of Lincoln's core values and leadership attributes

+ Leadership development and virtual training opportunities

+ PTO/parental leave

+ Competitive 401K and employee benefits (https://www.lincolnfinancial.com/public/aboutus/careers/lifeatlincoln#benefits)

+ Free financial counseling, health coaching and employee assistance program

+ Tuition assistance program

+ Work arrangements that work for you

+ Effective productivity/technology tools and training

The pay range for this position is $69,000 - $124,600 with **anticipated pay for new hires between the minimum and midpoint of the range** and could vary above and below the listed range as permitted by applicable law. Pay is based on non-discriminatory factors including but not limited to work experience, education, location, licensure requirements, proficiency and qualifications required for the role. The base pay is just one component of Lincoln’s total rewards package for employees. In addition, the role may be eligible for the Annual Incentive Program, which is discretionary and based on the performance of the company, business unit and individual. Other rewards may include long-term incentives, sales incentives and Lincoln’s standard benefits package.

**About The Company**

Lincoln Financial (NYSE: LNC) helps people to confidently plan for their version of a successful future. We focus on identifying a clear path to financial security, with products including annuities, life insurance, group protection, and retirement plan services.

With our 120-year track record of expertise and integrity, millions of customers trust our solutions and service to help put their goals in reach.

Lincoln Financial Distributors, a broker-dealer, is the wholesale distribution organization of Lincoln Financial. Lincoln Financial is the marketing name for Lincoln Financial Corporation and its affiliates including The Lincoln National Life Insurance Company, Fort Wayne, IN, and Lincoln Life & Annuity Company of New York, Syracuse, NY. Lincoln Financial affiliates, their distributors, and their respective employees, representatives and/or insurance agents do not provide tax, accounting or legal advice.

Lincoln is committed to creating an inclusive (https://www.lincolnfinancial.com/public/aboutus/companyoverview/ourvalues/diversityinclusion) environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

Follow us on Facebook (https://www.facebook.com/lincolnfinancial/) , X (https://mobile.twitter.com/lincolnfingroup) , LinkedIn (https://www.linkedin.com/company/lincolnfinancial/) , Instagram (https://www.instagram.com/lincolnfinancial/) , and YouTube (https://www.youtube.com/@Lincoln\_Financial) . For the latest company news, visit our newsroom (https://www.lincolnfinancial.com/public/aboutus/newsroom) .

**Be Aware of Fraudulent Recruiting Activities**

If you are interested in a career at Lincoln, we encourage you to review our current openings and apply on our website. Lincoln values the privacy and security of every applicant and urges all applicants to diligently protect their sensitive personal information from scams targeting job seekers. These scams can take many forms including fake employment applications, bogus interviews and falsified offer letters.

Lincoln will not ask applicants to provide their social security numbers, date of birth, bank account information or other sensitive information in job applications. Additionally, our recruiters do not communicate with applicants through free e-mail accounts (Gmail, Yahoo, Hotmail) or conduct interviews utilizing video chat rooms. We will never ask applicants to provide payment during the hiring process or extend an offer without conducting a phone, live video or in-person interview. Please contact Lincoln's fraud team at fraudhotline@lfg.com if you encounter a recruiter or see a job opportunity that seems suspicious.

**Additional Information**

This position may be subject to Lincoln’s Political Contribution Policy. An offer of employment may be contingent upon disclosing to Lincoln the details of certain political contributions. Lincoln may decline to extend an offer or terminate employment for this role if it determines political contributions made could have an adverse impact on Lincoln’s current or future business interests, misrepresentations were made, or for failure to fully disclose applicable political contributions and or fundraising activities.

Any unsolicited resumes or candidate profiles submitted through our web site or to personal e-mail accounts of employees of Lincoln Financial are considered property of Lincoln Financial and are not subject to payment of agency fees.

Lincoln Financial ("Lincoln" or "the Company") is an Equal Opportunity employer and, as such, is committed in policy and practice to recruit, hire, compensate, train and promote, in all job classifications, without regard to race, color, religion, sex, age, national origin or disability. Opportunities throughout Lincoln are available to employees and applicants are evaluated on the basis of job qualifications. If you are a person with a disability that impedes your ability to express your interest for a position through our online application process, or require TTY/TDD assistance, contact us by calling 260-455-2558.

This Employer Participates in E-Verify. See the E-Verify (https://www.e-verify.gov) notices.

Este Empleador Participa en E-Verify. Ver el E-Verify (https://www.e-verify.gov/es) avisos.

Lincoln Financial Group ("LFG") is an Equal Opportunity employer and, as such, is committed in policy and practice to recruit, hire, compensate, train and promote, in all job classifications, without regard to race, color, religion, sex (including pregnancy), age, national origin, disability, sexual orientation, gender identity and expression, veterans status, or genetic information. Opportunities throughout LFG are available to employees and applicants and are evaluated on the basis of job qualifications. We have a drug free work environment and we perform pre-employment substance abuse testing.

Our work matters. We help people get the medicine they need to feel better and live well. We do not lose sight of that. It fuels our passion and drives every decision we make.

**Job Posting Title**

HR Compliance Manager

**Job Description**

The HR Compliance manager will be joining Prime during an exciting and dynamic time for the HR Compliance function. The team has grown over the past couple of years, in size and scope, reflective of the evolving needs and size of the enterprise. As manager, you’ll be responsible for the planning, oversight, and management of the HR Compliance function, informing and executing overarching strategy. You’ll set the vision and tone for the team, providing direction, guidance and development, handling escalations, and collaborating with a broad network of HR leaders and partners across the organization. You’ll demonstrate a proactive approach to partnerships and a consultative, influential communication style to foster strong engagement with internal and external partners on a wide range of projects and programs.

**Responsibilities**

+ Manage overall service delivery of HR Compliance function, ensuring accuracy, timeliness and compliance; evaluate operational effectiveness of structure, programs and processes and implement streamlined, simplified and efficient ways of working

+ Provide work direction and guidance to the HR Compliance team to ensure appropriate work assignments and that work is executed in line with regulatory requirements and enterprise priorities; plan for and address capacity needs to support execution of deliverables

+ Manage escalated critical and complex issues; provide proactive solutions and determine appropriate course of action and escalation as needed; lead complex HR Compliance-related initiatives that affect multiple groups

+ Inform and execute HR Compliance strategic evolution, including scope of services

+ Provide mentorship and development to the HR Compliance team; drive the deepening and broadening of subject matter expertise, experience and relational skills across the team

+ Build collaborative relationships at all levels across the enterprise resulting in stakeholder alignment, effective communication strategies and overall satisfaction with HR Compliance practices

+ Stay current with legal, social and cultural landscape, along with emerging trends in the HR Compliance field

+ Manage relationships with external vendors providing HR Compliance services and resources, including ongoing evaluation of service levels, communication and issue resolution

+ Other duties as assigned

**Education & Experience**

+ Bachelor's degree in Human Resources, Business or related area of study, or equivalent combination of education and/or work experience; HS Diploma or GED is required

+ 6 years of work experience in compliance, legal, or regulatory focused role within Human Resources

+ 2 years of work experience in leadership/supervisory/people management

+ Must be eligible to work in the United States without the need for work visa or residency sponsorship

**Additional Qualifications**

+ Excellent communication skills with the ability to interface with all levels of the organization

+ Ability to develop and deliver presentations to internal stakeholders

+ Ability to handle ambiguous and stressful situations with confidence and diplomacy

+ Strong attention to detail, well organized and able to manage time effectively

+ Ability to analyze data and interpret requirements with a high level of accuracy and consistency

+ Proven ability to maintain discretion and confidentiality

+ Demonstrated understanding of state and federal employment and labor and HR compliance requirements

**Preferred Qualifications**

+ Master’s degree in a management, business or HR field

+ 10 years of experience working in compliance, legal, or regulatory focused role within Human Resources

+ 5 years of experience researching and interpreting HR and/or employment regulations

+ PHR (Professional Human Resources) Certification, Certified Compliance and Ethics Professional (CCEP) or Certified Project Management Professional (PMP)

+ Healthcare, insurance, or pharmaceutical industry experience

**Physical Demands**

+ Must be able to remain in a stationary position 50% of the time. Must be able to “move or traverse”

+ Must be able to constantly operate a computer and/or other office productivity equipment

+ Must be able to hear and constantly communicate information and ideas. Must be able to exchange accurate information

Every employee must understand, comply with and attest to the security responsibilities and security controls unique to their job, and comply with all applicable legal, regulatory, and contractual requirements and internal policies and procedures.

Potential pay for this position ranges from $81,000.00 - $138,000.00 based on experience and skills.

To review our Benefits, Incentives and Additional Compensation, visit our Benefits Page (https://www.primetherapeutics.com/benefits) and click on the "Benefits at a glance" button for more detail.

_Prime Therapeutics LLC is proud to be an equal opportunity and affirmative action employer. We encourage diverse candidates to apply, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sex (pregnancy, sexual orientation, and gender identity), national origin, disability, age, veteran status, or any other legally protected class under federal, state, or local law. _

_We welcome people of different backgrounds, experiences, abilities, and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law._

_Prime Therapeutics LLC is a Tobacco-Free Workplace employer._

Positions will be posted for a minimum of five consecutive workdays.

Prime Therapeutics' fast-paced and dynamic work environment is ideal for proactively addressing the constant changes in today's health care industry. Our employees are involved, empowered, and rewarded for their achievements. We value new ideas and work collaboratively to provide the highest quality of care and service to our members.

If you are looking to advance your career within a growing, team-oriented, award-winning company, apply to Prime Therapeutics today and start making a difference in people's lives.

Prime Therapeutics LLC is proud to be an equal opportunity and affirmative action employer. We encourage diverse candidates to apply, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sex (pregnancy, sexual orientation, and gender identity), national origin, disability, age, veteran status, or any other legally protected class under federal, state, or local law.

We welcome people of different backgrounds, experiences, abilities, and perspectives including qualified applicants with arrest and conviction records and any qualified applicants requiring reasonable accommodations in accordance with the law.

Prime Therapeutics LLC is a Tobacco-Free Workplace employer.

If you are an applicant with a disability and need a reasonable accommodation for any part of the employment process, please contact Human Resources at 1.866.469.1257 or email Careers@primetherapeutics.com.

**Amentum seeks a Cybersecurity Compliance Manager!**

**Amentum** is a global leader in advanced engineering and innovative technology solutions, trusted by the United States and its allies to address their most significant and complex challenges in science, security and sustainability. Headquartered in Virginia, we have more than 53,000 employees in approximately 80 countries across all 7 continents.

The **Cybersecurity Compliance Manager** is a remote-telework position that supports our compliance with cybersecurity related frameworks, in governance, risk, and information assurance. This role leads Amentum’s certification efforts for CMMC, ISO 27001, CE+, DIST, and others. Qualified candidates will need a versatile skill set that emphasizes CMMC and NIST 800-171 and 800-172 regulatory comprehension, technology, effective collaboration, critical thinking, analytical prowess, and strong communication skills. **Remote-telework role (you must live and work within the US). US Citizenship is required to apply. Seeking a candidate that is willing to obtain a secret level clearance.**

**Essential Responsibilities:**

+ CMMC Compliance & DIB Regulations: Oversee compliance with CMMC requirements, ensuring that internal controls for IT, cybersecurity, and risk management align with both CMMC requirements and industry-specific regulations, including Defense Federal Acquisition Regulation Supplement (DFARS) and National Institute of Standards and Technology (NIST) standards.

+ Control Testing & Documentation: Conduct regular testing of IT, cybersecurity, and risk controls to assess their operational effectiveness. Maintain thorough documentation of testing results, remediation plans, and updates related to NIST 800-171 and NIST 800-172 controls, while ensuring adherence to DIB-specific security guidelines.

+ Risk Assessment & Mitigation: Identify potential risks in IT systems and cybersecurity infrastructure that could affect compliance, data integrity, and operational continuity. Provide risk mitigation strategies tailored to the DIB environment, ensuring alignment with both regulatory and operational requirements.

+ Cybersecurity & Defense Controls: Review and evaluate the design and effectiveness of cybersecurity controls, particularly as they pertain to protecting sensitive defense-related information and intellectual property. Ensure cybersecurity controls meet or exceed government and DIB standards.

+ Cross-Department Collaboration: Collaborate with various business units, including IT, internal audit, cybersecurity, legal, and compliance teams, to ensure alignment with CMMC requirements and DIB-specific regulations. Advise and support these teams on best practices related to internal controls and risk management.

+ Continuous Improvement & Industry Best Practices: Keep up to date with developments in CMMC compliance, cybersecurity, IT risk management, and DIB-specific regulations. Propose improvements to internal controls and processes based on emerging threats, changing regulatory requirements, and industry best practices. Assist in crosswalks of frameworks, legislations and alike to controls.

+ Audit Support: Serve as a point of contact for internal & external auditors, ensuring timely and accurate delivery of documentation related to IT, cybersecurity, and risk controls. Address any findings or questions related to CMMC compliance and DIB-related security measures.

+ Compliance & Security Training: Provide guidance to internal stakeholders regarding compliance with CMMC and DIB regulations, including educating staff on internal controls, security requirements, and risk management procedures.

+ Consult with and brief executive management on CMMC compliance and risk matters.

+ Create, maintain, and provide metrics and status reports to cybersecurity leadership.

+ Travel up to 25%.

+ Perform all other position-related duties as assigned or requested.

**Knowledge, Skills, and Abilities:**

+ Strong understanding of CMMC/NIST 800-171 compliance.

+ Understanding specific regulations governing the DIB sector, including FAR, DFARS, NIST SP 800-53, NIST SP 800-171, CMMC, TAA, and ITAR.

+ Expertise in IT risk management, cybersecurity frameworks (e.g., NIST Cybersecurity Framework), and internal control methodologies (e.g., COSO, COBIT).

+ Ability to manage multiple priorities, work independently, and navigate complex regulatory environments in a highly sensitive and secure industry.

+ Excellent analytical, communication, and collaboration skills, with the ability to influence key stakeholders across the organization.

**Minimum Requirements** :

+ **US Citizenship is required.**

+ **Willingness to allow Amentum to obtain a secret level clearance for you.**

+ Bachelor’s degree in IT, Cybersecurity, or a related field.

+ **In lieu of a degree we will allow** : Two (2) years of hands-on experience in government regulatory compliance/IT or Cybersecurity for each year of the degree. (Eight (8) years of experience equals a Bachelor’s degree).

+ Eight (8) years of hands-on experience in government regulatory compliance efforts, such as RMF, CMMC, and FEDRAMP is **required** .

+ Relevant certifications such as CISA (Certified Information Systems Auditor), CISSP (Certified Information Systems Security Professional), or similar are highly **preferred.**

+ IT risk management or cybersecurity, **preferably** within the defense or government contracting industry.

Amentum is proud to be an Equal Opportunity Employer. Our hiring practices provide equal opportunity for employment without regard to race, sex, sexual orientation, pregnancy (including pregnancy, childbirth, breastfeeding, or medical conditions related to pregnancy, childbirth, or breastfeeding), age, ancestry, United States military or veteran status, color, religion, creed, marital or domestic partner status, medical condition, genetic information, national origin, citizenship status, low-income status, or mental or physical disability so long as the essential functions of the job can be performed with or without reasonable accommodation, or any other protected category under federal, state, or local law. Learn more about your rights under Federal laws and supplemental language at Labor Laws Posters (https://postings.govdocs.com/#/vxSkbztPuAwwxfs) .