EMEA Post-Market Surveillance Lead

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

Avantages offerts par ce poste

Flat hierarchies

Career development

Team spirit

Competitive salary & benefits

Recognition of performance

ERGs

Résumé du poste

Stryker in France is seeking a Regulatory Affairs professional to lead post-market surveillance activities across the EMEA region, ensuring compliance and timely regulatory reporting.

The role requires a Bachelor’s in Life Sciences or related field, 4+ years in regulatory affairs/QA, English fluency, and the ability to work with cross-functional teams across multiple countries. Hybrid work and occasional travel are offered.

Qualifications

• 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.
• Knowledge of Medical Device Regulations, post-market surveillance requirements, and quality management systems.
• Experience supporting regulatory reporting, product field actions, complaints, or post-market surveillance processes.

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 accurately identified and managed.
• Manage regulatory notifications and submissions to competent authorities, including responses to requests for additional information.
• Monitor regulatory developments and post-market surveillance intelligence, maintaining accurate documentation and sharing relevant 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, process adoption, and knowledge sharing across the organization.
• Contribute to process improvement initiatives, system implementations, and integration activities to enhance regional post-market surveillance effectiveness.

Connaissances

English fluency

Communication

Teamwork

Prioritization

Formation

Bachelor's degree in Life Sciences or related field

Description du poste

Stryker in France is seeking a Regulatory Affairs professional to lead post-market surveillance activities across the EMEA region, ensuring compliance and timely regulatory reporting.

The role requires a Bachelor’s in Life Sciences or related field, 4+ years in regulatory affairs/QA, English fluency, and the ability to work with cross-functional teams across multiple countries. Hybrid work and occasional travel are offered.