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,
  OR
  Five (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?

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