Lead Post Market Surveillance Specialist EMEA (m/f/x)
Stryker · Lyon, France +4 more
SafetyFull-timeCompany career page
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Role summary
Lead post-market surveillance activities for medical devices across the EMEA region, ensuring regulatory compliance and product safety. Coordinate field actions, manage regulatory submissions, and support cross-functional teams to maintain device effectiveness throughout their lifecycle.
What they're looking for
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related field
- Minimum 4 years in Regulatory Affairs, Quality Assurance, or post-market surveillance in medical device environment
- Knowledge of medical device regulations and quality management systems
- Experience with regulatory reporting, product field actions, complaints, or post-market surveillance processes
- Fluency in English; additional languages a plus
- Strong communication and interpersonal skills with ability to manage competing priorities
What you'll be doing
- Execute post-market surveillance activities in accordance with regulations and internal procedures
- Coordinate product field actions and commercial holds across EMEA region
- Manage regulatory notifications and submissions to competent authorities
- Monitor regulatory developments and maintain post-market surveillance documentation
- Analyze performance data, prepare reports, and develop training materials for compliance and process adoption
Privacy & handoff
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