Regulatory Affairs Specialists

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices. Job responsibilities include regulatory lead for change development projects, new product development, change assessment, US, EU and international regulatory submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business.

**_What is expected at this level:_**

+ Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects

+ May contribute to the development of policies and procedures

+ Works on complex projects of large scope

+ Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives

+ Completes work independently receives general guidance on new projects

+ Work reviewed for purpose of meeting objectives

+ May act as a mentor to less experienced colleagues

**_Responsibilities_**

+ The Principal Regulatory Affairs Specialist is responsible for the support of new product development and maintenance of business projects. Specific activities include but are not limited to:

+ Lead new and modified product development projects to establish and integrate regulatory strategy into project activities.

+ Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs.

+ Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution

+ Review design control documents including documents associated with design inputs and design outputs

+ Review product labeling for compliance with global labeling regulations

+ Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business

+ Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies

+ Maintain and provide regulatory information in support of customer queries, bid and tender submissions, customs queries, etc.

+ Development and implementation of regulatory procedures and SOPs

**_Qualifications:_**

+ Bachelor’s Degree in a scientific discipline preferred or equivalent work experience

+ 5-7 years Regulatory Affairs Experience, preferred

+ Majority of Regulatory Affairs experience in Medical Device industry preferred

+ You may be expected to travel up to 10% of the time

+ Proficiency in US and Europe medical device regulations

+ Strong organizational skills

+ Ability to manage multiple projects

+ Deadline conscious

+ Problem solving skills

+ Team oriented

+ Strong oral and written communication skills

**Anticipated salary range** : $79,700 - $113,800

**Bonus eligible** : No

**Benefits** : Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

+ Medical, dental and vision coverage

+ Paid time off plan

+ Health savings account (HSA)

+ 401k savings plan

+ Access to wages before pay day with myFlexPay

+ Flexible spending accounts (FSAs)

+ Short- and long-term disability coverage

+ Work-Life resources

+ Paid parental leave

+ Healthy lifestyle programs

Application window anticipated to close: 12/20/2024 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

\#LI-MP1

_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._

_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal_ _Opportunity/Affirmative_ _Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law._

_To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)

About the Company:

ANS provides industry-leading nutritional solutions to promote health and wellbeing, enabled by a world class team dedicated to service, excellence, quality, and innovation.

As an organization we take pride in achieving our objective of “More than Supplements... Solutions”... Safety. We want to be a “solution” through an engaged, accountable, and CARING culture.

If you are looking for an exciting career opportunity with a company that offers exceptional benefits packages, then you have come to the right place!

Most Competitive Pay in the Industry
401K Program
Paid holidays
Paid Time Off
Medical/Dental benefits
Employee and Family Events
Annual Awards Program
Best Employee Referral Program

The Opportunity…

Strong track record of internal promotions

Comprehensive Training program to encourage promotions

Detailed Progression model to outline promotional opportunities

Cross-functional opportunities to multiple different areas in the company

Requirements

Follow all company policies and procedures.

Follow and ensure compliance to quality system, Current Good
Manufacturing Practice, Food Safety Modernization Act, and all regulatory and company food and dietary supplement programs.

Track and report on regulatory changes.

Assist in audit preparation and closure of corrective actions.

Assist Sales and Customers with technical document requests.

Primary reviewer of Raw Material Specification Change Orders.

Communicate complex information and instructions plainly in technical writing and graphic communications, including standard operating procedures, manufacturing flow maps for export and

Preventive Control hazard risk analysis, spreadsheets, charts, graphs, reports, and presentations.

Coordinate with suppliers and customers as needed.

Ensure that programs and plans comply with regulatory requirements.

Responsible for vendor requalification and service provider qualification program.

Submit products for certification and provide lead support for certification programs such as

Non-GMO Project, Organic, Kosher, Halal, MSC, NSF, etc.

Lead support for resolving receiving holds.

Assist with maintenance of Internal Audit Program.

Collaborate inter-departmentally and externally with certification agencies to resolve Quality, Regulatory, and Certification Compliance issues expeditiously.

Qualifications

Must have a high school diploma or equivalent.
Two years of experience in an FDA-regulated industry preferred.
Must obtain PCQI and FSVP Certification within 1 year of hire.
Must have moderate math skills and data analysis skills.
Complex reading skills required, including relevant regulations.
Complex computer skills required. Proficiency in Microsoft Excel, Word, Visio, and Adobe Acrobat Pro.
Must have complex language skills, including technical writing and instructional design skills.
Must be willing to learn new tasks and procedures and be able to train others.
Must be able to efficiently and effectively perform all essential position duties and responsibilities with or without reasonable accommodation without posing a direct safety threat to self or others.
Maintain a regular and dependable work attendance record with few instances of unplanned and/or unexpected absence.
Must have experience with managing and building workflows in document management systems.