Lead Post Market Surveillance Specialist EMEA (m/f/x)

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

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.

Make a meaningful impact on patient safety and product quality across the EMEA region. In this role, you will help ensure medical devices remain safe, effective, and compliant throughout their lifecycle by supporting post-market surveillance activities and regulatory reporting processes. You will work across multiple countries and functions, partnering with regulatory, quality, commercial, and operational teams to drive compliance, continuous improvement, and business continuity.

As this position is part of an international team, we kindly ask that you submit your CV in English.

What You Will Do

• 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.

What You Will Need

Required 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.

• Fluency in English; additional languages will be considered a plus.
• Strong communication and interpersonal skills, with a positive, team-oriented mindset and the ability to remain effective under pressure while managing competing priorities.

Preferred Qualifications

• Regulatory Affairs Certification (RAC).
• Experience working across multiple countries or regions within the medical device industry.

Additional Information

• Work arrangement: Hybrid working model based on business and country requirements.
• Travel: Occasional regional travel may be required.

At Stryker, we are looking for responsive, determined, and energetic professionals who are passionate about advancing patient safety, quality, and regulatory excellence while collaborating across a dynamic international environment.

What we offer

• Flat hierarchies and responsibility.Through flat hierarchies, we strengthen the initiative and willingness of our employees to take over responsible tasks.
• We grow talent.At Stryker we offer great personal and internal career development for our employees, with the possibility to make both vertical and lateral position movement.
• Team spirit & engagement.We create engaged and inclusive teams that encourage colleagues to share their diverse perspectives and opinions.
• Competitive salary and Benefits.With us, you will receive a competitive salary and benefits commensurate with your job.
• Recognition of your performance.At our company, outstanding individual and cross-functional team performance is rewarded. Ideas, projects, or other exceptional achievements can be submitted for various awards on a local and global level.
• Employee Resource Groups (ERGs).Our ERGs are dedicated to fostering an inclusive, diverse, and supportive workplace environment. They provide opportunities for development, networking, and collaboration, and are open to all employees. Our ERGs are committed to promoting inclusion and belonging, helping every individual thrive and contribute to our shared success.
• Know someone at Stryker? Be sure to have them submit you as a referralprior to applyingfor this position. Learn more about ouremployee referral programat https://careers.stryker.com/referrals/

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

France Pay Ranges:

• France: €45.500 - €75.900 EUR Annual

Germany Pay Ranges:

• Berlin/Duisburg/Waghäusel/field-based 40Std: €69.400 - €115.700 EUR Annual

Spain Pay Ranges:

• Spain: €44.000 - €73.400 EUR Annual

Ireland Pay Ranges:

• Ireland: €54,000 - €90,000 EUR Annual

Romania Pay Ranges:

• Romania: lei12.300 - lei20.400 RON Monthly

Chez Stryker, nous pensons que la transparence aide les candidats à prendre des décisions éclairées concernant la prochaine étape de leur carrière. La rémunération constitue un élément important de ce processus et nous souhaitons expliquer clairement comment elle est déterminée. Les informations de rémunération publiées pour ce poste peuvent être présentées sous la forme d’une fourchette salariale ou d’un montant fixe, selon le poste concerné. En plus du salaire de base, ce poste peut donner droit à une rémunération variable (telle qu’une prime et/ou des commissions, le cas échéant), ainsi qu’au programme complet d’avantages sociaux de Stryker.

Si vous souhaitez en savoir plus sur le salaire ou les avantages associés à ce poste, votre recruteur ou votre recruteuse se fera un plaisir de vous en expliquer les détails au fur et à mesure de votre progression dans le processus de recrutement.