Sr Staff Regulatory Affairs Specialist - United States
1. Assesses regulatory pathways for new product development and product modifications; develops regulatory strategies and tactical plans for submissions to FDA, NSAI and other regulatory agencies.
2. Identifies and communicates potential risks and mitigation associated with regulatory strategies to stakeholders.
3. Preparation of PMAs, 510(k) s, Technical Files/Documentation, and documentation for ex-U.S. registrations;
4. Participates in interactions/negotiations with U.S. regulatory agencies
5. Monitors regulatory developments affecting BD programs and communicates emerging opportunities and concerns to stakeholders (e.g., Leadership Team, Project Teams).
6. Represents BD in external activities (e.g., standards organizations).
7. Supports the regulatory review of labeling and promotional materials.
8. Reviews clinical protocols and reports to assure collection of appropriate data for regulatory submissions.
9. Ensures FDA device listings and facility registrations are maintained.
10. Ensures that RA departmental policies, procedures, and records comply with applicable regulations and standards.
11. Remains current on regulations affecting BD products (MDD, IVD, RUO/IUO policies, CLIA, reclassification activities, etc.).