What are the responsibilities and job description for the Regulatory Affairs Manager position at BioTalent?
Regulatory Affairs Manager – Post‑Market Compliance & Recalls
A global medical device and diagnostics manufacturer is seeking an experienced Regulatory Affairs Manager to lead post‑market regulatory activities across worldwide markets. This role is ideal for someone who excels in recall management, global vigilance, and building high‑performing teams.
What You’ll Do
- Lead and develop a team of post‑market regulatory professionals.
- Serve as the primary leader for field corrections and removals, including risk assessment, strategy, agency reporting, and cross‑functional execution.
- Oversee global vigilance and adverse event reporting programs (FDA, Health Canada, international).
- Drive global Post‑Market Surveillance (PMS) programs, including EU IVDR‑aligned plans and reports.
- Evaluate regulatory impact of design, labeling, and manufacturing changes to on‑market products.
- Represent RA during inspections, audits, and internal reviews.
- Monitor evolving worldwide regulations and guide teams on compliance implications.
What We’re Looking For
- Bachelor’s degree in a scientific or regulatory field.
- 7 years of management experience (medical devices preffered).
- Required: Direct experience with FDA and Health Canada adverse event reporting and recall processes.
- Experience with international vigilance and recalls is a strong advantage.
- Knowledge of regulations such as 21 CFR 803/806/820, ISO 13485, MDSAP, and EU IVDR preferred.
- Strong communication, leadership, problem‑solving, and audit‑readiness skills.
Salary : $160,000 - $190,000