Lead Post Market Surveillance Specialist EMEA

About the role

Join Stryker’s award‑winning team to ensure medical devices remain safe, effective, and compliant across the EMEA region. You will lead post‑market surveillance activities, coordinate field actions, and support regulatory reporting while collaborating with cross‑functional teams.

Key responsibilities

• Execute post‑market surveillance activities in line with regulations, quality requirements and internal procedures.
• Coordinate product field actions and commercial hold activities across EMEA, ensuring accurate identification and management of impacted products and customers.
• Manage regulatory notifications and submissions to competent authorities, including responses to requests for additional information.
• Monitor regulatory developments and post‑market surveillance intelligence, maintaining documentation and sharing updates with stakeholders.
• Support country and regional teams to ensure operational continuity and consistent execution of post‑market surveillance processes.
• Analyze performance data, prepare metrics and reports, and provide insights to support quality and regulatory objectives.
• Develop, update and deliver training materials to promote compliance and knowledge sharing.
• Contribute to process improvement initiatives, system implementations and integration activities to enhance regional effectiveness.

Required profile

• Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, Quality or a related field.
• Minimum 4 years of experience in Regulatory Affairs, Quality Assurance, Post‑Market Surveillance or a related medical‑device environment.
• Fluency in English; additional languages are a plus.
• Strong communication and interpersonal skills with the ability to work under pressure.

Required skills

• Knowledge of Medical Device Regulations and post‑market surveillance requirements.
• Experience with regulatory reporting, product field actions, complaints handling and quality management systems.
• Ability to analyze data, prepare metrics and generate reports.

What we offer

• Flat hierarchies with responsibility and initiative.
• Opportunities for personal and internal career development, including vertical and lateral moves.
• Engaged, inclusive team environment encouraging diverse perspectives.
• Competitive salary and benefits package.
• Recognition programs for individual and team performance.
• Employee Resource Groups fostering inclusion and belonging.