EMEA Post-Market Surveillance Lead — Regulatory & Quality

Stryker Corporation; Lyon; Hybride; EUR 46 000 - 76 000; Plein temps

Avantages offerts par ce poste

Flat hierarchies

Career development

Team engagement

Résumé du poste

Stryker Corporation in Lyon, France (hybrid) is seeking a Lead Post Market Surveillance Specialist EMEA to ensure medical devices remain safe, compliant, and effective across the region. You will drive post-market surveillance and regulatory reporting across multiple countries, collaborating with regulatory, quality, and operations teams.

The role requires a life sciences or engineering degree, 4+ years in regulatory affairs or quality in medical devices, and strong English communication.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related field.
• 4+ years of experience in Regulatory Affairs or Post-Market Surveillance in a medical device environment.
• Knowledge of Medical Device Regulations, post-market surveillance requirements, and quality management systems.
• Fluency in English; additional languages will be considered a plus.

Responsabilités

• Execute post-market surveillance activities in accordance with applicable regulations, quality requirements, and internal procedures.
• Coordinate product field actions and commercial hold activities across the EMEA region, ensuring impacted products and customers are identified and managed.
• Manage regulatory notifications and submissions to competent authorities, including responses to information requests.
• 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 support compliance and knowledge sharing across the organization.
• Contribute to process improvement initiatives, system implementations, and integration activities to enhance regional post-market surveillance effectiveness.

Connaissances

Regulatory affairs

Post-market surveillance

Quality assurance

Regulatory reporting

Cross-country teamwork

English fluency

Formation

Bachelor's degree in Life Sciences

Engineering or Regulatory related field

Description du poste

Stryker Corporation in Lyon, France (hybrid) is seeking a Lead Post Market Surveillance Specialist EMEA to ensure medical devices remain safe, compliant, and effective across the region. You will drive post-market surveillance and regulatory reporting across multiple countries, collaborating with regulatory, quality, and operations teams.

The role requires a life sciences or engineering degree, 4+ years in regulatory affairs or quality in medical devices, and strong English communication.