Quality and Regulatory Affairs Specialist

Join the team dedicated to ensuring the safety, quality, and compliance of life-saving medical devices. In this role, you will contribute directly to post-market surveillance and vigilance activities, helping to protect patients while supporting global regulatory compliance. This is an excellent opportunity for an early-career regulatory or quality professional looking to build expertise in medical device regulations and quality systems within a collaborative and mission-driven environment.

• Review product complaints and assess regulatory reportability within established timelines.
• Manage complaint handling activities, including documentation, tracking, and follow-up actions.
• Review and approve complaint investigations to support timely and compliant resolution.
• Prepare and submit initial and follow-up vigilance reports to regulatory authorities in accordance with applicable requirements.
• Maintain systems and records used to monitor, track, and report product complaints and adverse events.
• Partner with investigators, local teams, customers, and regulatory agencies to collect information required for reportability assessments and investigations.
• Support audits, field actions, recalls, nonconformance investigations, and corrective and preventive action activities to maintain compliance.
• Contribute to the development and maintenance of regulatory procedures, standard operating procedures, and post-market surveillance processes.

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or a related field.
• Proficiency with computer-based systems and standard business software applications.
• Fluent in English (written and spoken).

• Minimum 1 year of experience in Regulatory Affairs, Quality Assurance, Post-Market Surveillance, Complaint Handling, Medical Device Vigilance, or a related regulated environment.
• Master’s degree in Regulatory Science or a related discipline.
• Experience working within the medical device, healthcare, pharmaceutical, or other regulated industry.
• Knowledge of 21 CFR Part 820 Quality System Regulation.
• Knowledge of 21 CFR Part 803 Medical Device Reporting requirements.
• Knowledge of European Medical Device Regulation (EU MDR) 2017/745.
• Knowledge of ISO 13485:2016 Medical Devices Quality Management Systems.
• Knowledge of HIPAA requirements and General Data Protection Regulation (GDPR) 2016/679.
• Experience supporting complaint investigations, post-market surveillance, or vigilance reporting activities.

• Flat hierarchies and a culture committed to achieve our mission and deliver remarkable results.
• We grow talent: we offer great personal and internal career development for our employees, with the possibility to make both vertical and lateral position movement.
• An attractive salary and benefits package.
• Recognition of your performance: at Stryker, 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.
• Collaborative and inclusive environment: join a team that values diversity and inclusion, fostering a supportive and innovative workplace.
• Ability to discover your strengths, follow your passion and own your career.

Netherlands: €42.000 - €78.000 EUR Annual

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Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more…