Quality and Regulatory Affairs Specialist

• 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.

• Bachelors 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.
• Masters 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.

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 addition to base salary this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable) along with Strykers comprehensive benefits package.

If youd 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.