Overview
In this hybrid role, you contribute to post-market surveillance, vigilance activities, and regulatory compliance for life-saving medical devices. You will work with cross-functional teams to ensure timely, compliant handling of complaints and investigations, supporting audits and corrective actions. The role offers growth in regulatory and quality systems within a mission-driven environment. You will help protect patients while advancing regulatory knowledge and processes.
Arbeidsvoorwaarden / Benefits
- flat hierarchies
- career development
- competitive salary and benefits package
- recognition programs
- collaborative and inclusive environment
- global opportunities
Verantwoordelijkheden
- Review complaints and assess reportability within timelines
- Manage complaint handling, including documentation and follow-up
- Review and approve investigations to support timely resolution
- Prepare and submit vigilance reports to authorities
- Maintain systems to monitor, track, and report complaints/adverse events
- Collaborate with investigators, teams, customers, and regulators for information collection
- Support audits, field actions, recalls, nonconformance investigations, and CAPA
- Contribute to development and maintenance of regulatory procedures and post-market surveillance processes
Belangrijkste vereisten
- 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)
- Collaboration across cross-functional teams
- Attention to detail
- Effective communication
- 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
Quality and Regulatory Affairs Specialist in Maastricht werkgever: Jobrapido
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