Quality and Regulatory Affairs Specialist

Job description

Work Flexibility: Hybrid Join a 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 Required Qualifications 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 At Stryker, we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the role. In addition to base salary, this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable), along with Stryker’s comprehensive benefits package. If you’d like to learn more about the salary or the benefits associated with this role, your recruiter will be happy to walk you through the details as you progress through the hiring process. Travel Percentage: 10%