Director, Global Product Monitoring & Post‑Market Surveillance

Key Responsibilities

• Develop and execute global product monitoring and post‑market surveillance (PMS) strategy for combination products.
• Lead post‑market professionals for complaint handling, complaint determination/evaluation, vigilance reporting, field action/recall execution, and Annual Product Quality Review (APQR) management.
• Ensure compliance with global regulations/procedures for complaint and reportable event handling, including issuance of initial, supplemental, and final regulatory reports.
• Lead APQRs and integrate complaint trends, field performance, CAPA effectiveness, and stability data.
• Ensure compliance with 21
  
  CFR Part4,820,211,6xx, ISO 13485, and ISO 14971.
• Collaborate cross‑functionally (Medical Affairs, Regulatory, Quality Engineering, Quality Risk Management, Operations) to improve customer experience across the product lifecycle.
• Conduct signal detection and trending analysis for emerging risks; elevate and engage global stakeholders for rapid response.
• ~20% travel to France.

• Bachelor’s degree in a relevant field; advanced degree preferred; regulatory and/or QA certifications a plus.
• 10–12+ years increasing responsibility in biotechnology/pharmaceutical GxP Quality & Compliance.
• Combination product/medical device/drug/biologics experience preferred.
• 7–10 years management experience in global environments.
• Experience leading complaint handling and regulatory reporting; leading field actions/recalls.
• Deep expertise in global PMS and APQR; strong knowledge of ISO 14971 and root cause tools.
• 5+ years with 1+ eQMS platforms (Veeva/ENNOV desired).

• Practical knowledge of FDA/ICH/GxP requirements to maintain and expand a product monitoring/PMS program.
• Experience implementing QMS/Governance meeting 21 CFR 211/820, ICH Q8/9/10, and ISO 13485 (21
  
  CFR part 6xx desired).
• Knowledge of design controls and human factors; strong communication, analytical, and conflict‑resolution skills.
• Fluent English required;
  French a plus.