Job Description Summary

Reporting to BD Biosciences (BDB) Sr. Director of Regulatory Affairs, and supporting the clinical platform leader of BDB, the Director of Regulatory Affairs (RA) provides pre-market regulatory leadership to BDB, and serves as a member of the BDB Clinical Platform Leadership Team and BD RA extended LT. This individual directs the premarket regulatory affairs activities within BDB, which includes interactions between BDB and US FDA, BDB and Notified Body as well as health ministries outside of the US and EU as required. He/she contributes to the development of BDB strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development in support of worldwide registrations. The Director will ensure functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of BDB products with desired claims. He/she is responsible for talent development, budgets, and plans for the BDB premarket Regulatory Affairs group. Additionally, this individual plays an active role in external industry group efforts to shape policies, guidance, and standards that are of strategic importance to BDB. This individual will communicate new developments in worldwide regulations affecting BDB products to BDB stakeholders.





The RA Director facilitates the resolution for complex problems requiring exercise of foresight, strategic and analytical skills while exercising independent judgment and discretion within broadly defined practices and policies. This individual interprets subjective and complex aspects of specific regulations and has a general understanding of multiple sets of associated regulations.

Job Description

Job Description Summary

Reporting to BD Biosciences (BDB) Sr. Director of Regulatory Affairs, and supporting the clinical platform leader of BDB, the Director of Regulatory Affairs (RA) provides pre-market regulatory leadership to BDB, and serves as a member of the BDB Clinical Platform Leadership Team and BD RA extended LT. This individual advises the premarket regulatory affairs activities within BDB, which includes interactions between BDB and US FDA, BDB and Notified Body as well as health ministries outside of the US and EU as required. They contribute to the development of BDB strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development in support of worldwide registrations. The Director will ensure functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of BDB products with desired claims. They are responsible for talent development, budgets, and plans for the BDB premarket Regulatory Affairs group. Additionally, this individual plays an active role in external industry group efforts to craft policies, guidance, and standards that are of strategic importance to BDB. This individual will communicate new developments in worldwide regulations affecting BDB products to BDB team members.

The RA Director facilitates the resolution for sophisticated problems requiring exercise of foresight, strategic and analytical skills while exercising independent judgment and discretion within broadly defined practices and policies. This individual interprets subjective and complex aspects of specific regulations and has a general understanding of multiple sets of associated regulations.

Responsibilities:

• Develops regulatory strategy for IVD and CDx and ensures timely execution of the strategy and activities related to US and EU registrations, and designated compliance activities from moderate to high complexity.

• Coordinates and advises the preparation of complex regulatory submissions, including Premarket (510(k)) Notifications, de novo applications, EU Technical Files for CE mark (IVDD/IVDR, and Machinery Directive), pre-Submission documentation, Premarket Approval Applications (PMA), laser reports, WHO pre-qualification submissions, and materials required for registration of products outside the U.S. and EU.
• Represents the business in interactions and negotiations with regulatory agencies and notified bodies about premarket submission requirements, acceptable labeling claims, etc. Organizes and leads meetings with regulators, including development of agendas, preparation of materials, and training/preparation of company personnel attending the meetings.
• Provides a high degree of regulatory expertise and experience to BDB’s new product development programs, serving as a Core Team advisor and champion for BDB’s Globa