Senior Manager Post Market Surveillance
2 weken geleden
Senior Manager Post Market Surveillance
We are partnering with a leading global Medical Device company seeking a Sr. Manager Post Market Surveillance. This is an exciting opportunity to lead complaint handling, recalls, trend reporting, and all Post Market Surveillance (PMS) activities across multiple European entities.
Location: Utrecht, Netherlands - Hybrid
Scope: EMEA Post Market Surveillance & Compliance
The Role
As Sr. Manager Post Market Surveillance, you will oversee end-to-end complaint handling, recall management, and regulatory reporting for medical devices distributed across the EMEA region. You will collaborate with cross-functional teams, ensuring compliance with ISO 13485, EU MDR 2017/745, and other relevant regulations. This role requires strong leadership in driving continuous improvement within PMS processes.
Key Responsibilities
- Develop and implement a strategic vision for complaint handling and recall management, ensuring alignment with global standards.
- Oversee the complaints process, including risk classification, investigations, and resolution, while establishing and monitoring complaint handling metrics.
- Manage vigilance reporting, including manufacturer incident reports (MIR) and acting as the primary contact for regulatory authorities.
- Lead Field Safety Corrective Actions (FSCA) and recall execution across EMEA, collaborating with internal teams to ensure robust investigations.
- Maintain Post Market Surveillance Plans and Reports, perform Health Hazard Evaluations (HHE), and ensure compliance with regulatory requirements.
- Act as a Subject Matter Expert (SME) for internal and external audits related to PMS and complaint handling.
- Lead, mentor, and develop a distributed team across multiple European locations, providing training on PMS procedures.
Qualifications & Experience
- Bachelor's degree in Science, Engineering, Healthcare, or related field.
- 8+ years of experience in medical device post-market surveillance, complaint handling, and recall management.
- Strong knowledge of ISO 13485, EU MDR 2017/745, and medical device regulatory requirements.
- Proven experience managing multi-site teams in a global environment.
- Excellent organizational, analytical, and problem-solving skills.
- Strong ability to collaborate cross-functionally in a regulated industry.
- Fluency in English required; French is preferred.
- Experience with regulatory communication (e.g., ANSM) preferred.
- Willingness to travel frequently across Europe.
Why Join?
Take on a high-impact leadership role in a global Medical Device company, driving compliance, continuous improvement, and best practices in Post Market Surveillance. This is an opportunity to shape regulatory strategy and enhance product safety across the EMEA region.
How to Apply
If you are an experienced quality leader in Post Market Surveillance within MedTech, Life Sciences, or Pharmaceuticals, we'd love to hear from you.
Apply now or contact Aimee Brenner at a.brenner@panda-int.com for more information.
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