Complaint Handling & Vigilance Manager — MedTech
Location: Utrecht, Netherlands (EU-based)
Employment type: Permanent
Function: Quality / Post-Market Surveillance (PMS)
Reporting to: Senior Manager, Post Market Surveillance EMEA
Team management: Yes (Complaint & Vigilance Specialists across multiple locations)
The Opportunity
Panda is supporting a global medical device manufacturer with a key hire in their EMEA QARA organization. As a Complaint Handling & Vigilance Manager, you will lead and continuously improve the end-to-end complaint handling and vigilance/incident reporting process across EMEA, ensuring compliance with EU MDR 2017/745 and related standards.
This role is ideal for a medical device quality leader with strong regulatory vigilance knowledge, experience managing multi-site teams, and a proactive mindset for process improvement and compliance excellence.
Key Responsibilities
Complaint Handling & Vigilance Leadership
- Own and drive the end-to-end complaint handling process, including data collection, risk-based classification, investigation oversight, and documentation.
- Lead incident reporting activities, including reportability assessments, approvals, submissions, and lifecycle management.
- Ensure complaint files are complete, accurate, and processed within required timelines.
Regulatory Reporting & Authority Interaction
- Prepare, submit, and manage Manufacturer Incident Reports (MIRs) to relevant European Competent Authorities in line with EU MDR Articles 87–90 (and other applicable reporting obligations).
- Act as the vigilance contact for authorities; manage correspondence with Competent Authorities and Notified Bodies related to reportable events and vigilance topics.
Cross-Functional Collaboration
- Partner with internal stakeholders (e.g., Quality, Regulatory, Clinical, Product Management, Manufacturing, Suppliers) to ensure robust investigations and corrective actions.
- Support complaint trending, supplier actions (e.g., quality notifications / SCARs), and overall product quality improvements.
- Contribute to post-market deliverables including PMS plans and PMS reporting/PSUR in collaboration with Regulatory Affairs.
Process Optimization & Continuous Improvement
- Optimize tools, workflows, and procedures to improve compliance, efficiency, and effectiveness.
- Harmonize ways of working across different sites/locations.
- Establish and track KPIs/metrics for complaint handling and ensure targets are met.
People Leadership & Training
- Lead, mentor, coach, and develop Complaint Handling & Vigilance Specialists across multiple locations.
- Build and deliver training materials and ensure teams are trained on complaint handling, incident reporting, and trending procedures.
Audit Readiness
- Serve as the subject matter expert during internal and external audits related to complaint handling, vigilance, and complaint trending.
Requirements
- EU-based (must be located in the EU).
- Bachelor’s degree in a relevant discipline (e.g., nursing, engineering, science, healthcare, or similar).
- 5+ years experience in the medical device industry.
- Strong working knowledge of:
- ISO 13485
- EU MDR 2017/745
- Proven experience in complaint handling and vigilance/incident reporting for medical devices.
- Experience leading teams across multiple locations and working effectively cross-functionally.
- Excellent communication skills (written and spoken).
- English fluent required
- German and/or French preferred
- Strong organizational and analytical skills.
- Experience communicating with local authorities (e.g., ANSM) is a plus.
- Willingness to travel across Europe as needed.
Interested?
If you’d like to learn more or discuss the role confidentially, apply via Panda or reach out to the Panda team directly.