Quality and Regulatory Affairs Specialist

Stryker Corporation; Maastricht; Hybrid; EUR 42,000 - 78,000; Full time

Benefits offered by this job

Salary and benefits package

Career development

Job summary

Stryker Corporation is hiring for a regulatory/post-market surveillance professional in the Netherlands. The role focuses on review of complaints, vigilance reporting, and regulatory compliance across audits and investigations in a hybrid work setting with occasional travel.

Requirements include a bachelor’s degree in a relevant field, English fluency, and 1+ year in regulatory or quality roles within medical devices or related regulated industries.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or 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 related regulated environment.

Responsibilities

• 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.

Skills

English fluency

Regulatory knowledge

Education

Bachelor’s degree in Engineering, Life Sciences, Regulatory Science, or related field

Tools

Computer software proficiency

Job description

Work Flexibility: Hybrid

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.

What You Will Do

• 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.

What You Will Need

• 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).

Preferred Qualifications

• 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.

What we offer:

• 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 Pay Ranges:

Netherlands: €42.000 - €78.000 EUR Annual

Travel Percentage:

10%

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 information, visit: www.stryker.com

Work Flexibility Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.