Regulatory Affairs Specialists

**Job Description Summary**

As Regulatory Affairs (RA) Specialist, you will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. The RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns. Candidates must be able to work in our Tempe, AZ office 3 days a week.

**Job Description**

We are **the makers of possible**

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a **maker of possible** with us.

**Primary Job Responsibilities:**

+ Understands fundamental global regulatory requirements and different regulatory pathways.

+ Understands scientific and health principles related to healthcare product development and regulations.

+ Participates in core teams as regulatory lead and provides guidance on regulatory requirements to product development teams, with some support from management.

+ Assists and/or has ownership in preparation of dossiers and submission packages for regulatory agencies.

+ Supports development of regulatory strategies for marketing authorization for global markets.

+ Independently reviews product changes to ensure regulatory compliance. Communicates changes to global regions and supports preparation of global notifications as needed.

+ Assists in the preparation and sending of post-market reports and submissions.

+ Participates in training of colleagues, as needed, for areas of expertise.

+ Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends.

+ Maintains regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s).

+ May participate in regulatory body audits, as related to respective product line(s) and/or region(s).

**About You:**

+ Minimum bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field and a minimum of one year of experience, or equivalent combination of related education and experience.

+ Minimum of two years of regulatory or quality experience in the medical device industry.

+ Ability to plan and schedule multiple priorities in a concurrent fashion.

+ Ability to review, collate, and summarize scientific and technical data.

+ Ability to learn new technical concepts and skills.

+ Excellent problem solving and analytical skills.

+ Excellent written and oral communication skills.

**Preferred Qualifications:**

+ Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.

+ Ability to complete work with minimal supervision and ability to work independently.

+ Previous experience in regulatory body audit support.

+ Experience with regulatory tools and systems.

+ Excellent writing and strong organizational skills.

+ International regulatory experience.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

**Why Join Us?**

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

\#earlycareer

**Primary Work Location**

USA AZ - Tempe Headquarters

**Additional Locations**

**Work Shift**

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries , extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

**Responsibilities**

Global – Responsible for the overall product strategy, global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance, regulatory intelligence and change management.

Regional and/or Local - Responsible for pharmaceutical, consumer and medical device regulations in Regional and Local markets. The team partners closely with commercial leaders to define strategy and execute registrations, provides regulatory intelligence and ensures regulatory compliance.

Act as primary contact with regulatory authorities with supervision.

**Requirements**

+ Minimum Associate degree, Bachelor degree preferred or equivalent

+ Minimum of 1.5 years Regulatory Affairs experience or relevant experience in a regulated environment

+ Some skills in basic technologies (e.g., MS Office Applications, Adobe Acrobat, MS Project)

+ Some knowledge of country regulations (med device, IVD's ( _In vitro diagnostics_ ), and pharma), post-market surveillance, ISO and IEC

+ Command of English language (verbal and written)

+ Working knowledge of dossier section authoring and compilation for submissions

+ Thorough understanding of regulatory processes and information systems

**Other Skills**

+ Excellent communication / interpersonal and writing

+ Self-motivated and capable of working independently with minimal supervision

+ Detail oriented with the ability to proofread and check documents for accuracy and inconsistencies

+ Ability to work and contribute to a team environment

+ Ability to understand scientific information and start to assess whether technical arguments are articulated clearly

+ Knowledge of good documentation practices

+ Operates with a sense of urgency

+ Demonstrated ability in analytical reasoning and critical thinking skills

+ Ability to handle multiple tasks and meet deadlines

+ Ability to support internal/external business stakeholders

+ Demonstrated ability to contribute to a continuous learning and process improvement environment

+ Capacity to react quickly and decisively in unexpected situations

This position may be available in the following location(s): [[location_obj

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

For U.S. locations that require disclosure of compensation, the starting pay for this role is between $65,000 to $95,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors. U.S. based employees may be eligible for short-term and/or long-term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms. To learn more please read Bausch + Lomb's Job Offer Fraud Statement (https://performancemanager.successfactors.eu/doc/custom/BauschLomb/Bausch\_job\_posting\_statement.docx) .

Our Benefit Programs: Employee Benefits: Bausch + Lomb (https://www.bausch.com/careers/benefits/)

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.