BD (Becton, Dickinson and Company) Jobs

Job Description Summary

The Senior Regulatory Affairs (RA) Specialist within the BD Interventional Surgical Devices Business unit will work on regulatory strategy and submissions for Implantable and Absorbable devices. Under the mentorship of the Senior Manager of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions. The Senior RA Specialist will provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents). The incumbent should have demonstrated leadership and success working in cross-functional teams and will perform essential duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates.

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.

Responsibilities

• Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)

• Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required

• Prepare and update STED technical files for CE marking activities and notified body interaction

• Identify and communicate appropriately quantified risks and mitigations associated with regulatory strategies to cross-functional stakeholders.

• Provide cross-functional support for regulatory submissions and compliance, including approval of product labeling, promotional, and advertising materials; review of clinical and human factors protocols; regulatory leadership on business continuity projects and writing/updating standard operating procedures, work instructions, and policies.

• Provides regulatory support during internal/external audits and inspections.

• Provide timely review and approval of product labeling and marketing claims for regulatory compliance

Qualifications

• B.A. or B.S. degree in a technical field preferred (e.g., engineering, biology, chemistry, health science). B.A. or B.S. in other field acceptable with appropriate level of experience.

• Three (3) years Regulatory Affairs experience with medical devices or in vitro diagnostic devices with proven success in the preparation and completion of regulatory submissions (PMA, 510(k), IDE, Pre-submissions) to the FDA and other global regulatory agencies,ORFive (5) years experience with medical devices in other functions (e.g., QA, R&D, etc.) with demonstrated support of regulatory submission development and approval from the FDA and other global regulatory agencies.

Knowledge, Skills, And Abilities

• Knowledge of the U.S. and European medical device regulations

• Excellent written and verbal communication skills

• Self-motivated, work independently and have the ability to take ownership of responsibilities

• Must be able to prioritize and handle several projects concurrently

• Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience

• Proficient in using Microsoft Word, Excel and PowerPoint

• Strong communication (written, oral) and project management skills.

• Nice to have – RAC

• Nice to have - previous experience managing class III devices

• Nice to have – knowledge of RIM

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.

PDN

Primary Work Location

USA RI - Warwick

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.