Support and further development of the quality management system in accordance with DIN EN ISO 13485 and the EU AI Act
Support with national and international approval and registration processes
Participate in the risk management process according to ISO 14971 across the entire product lifecycle
Operational implementation of Post-Market Surveillance (PMS) and vigilance, including reporting and communication with authorities
Handling of CAPA, nonconformities, and customer complaints, and follow-up on corrective actions
Support in planning, conducting and follow-up of internal and external audits as well as supplier qualification
Participation in Computerized System Validation (CSV) including risk analysis, test planning, execution and documentation

Degree in a scientific or technical field (e.g., medical technology, engineering, life sciences, quality management) or equivalent qualification
At least 2 years of relevant professional experience in quality management and/or regulatory affairs in medical devices
Solid knowledge of the requirements of ISO 13485, ISO 14971 and the EU Medical Device Regulation (MDR), including practical experience in Post-Market Surveillance (PMS) and vigilance
Experience handling CAPA, complaints and audit preparations
Knowledge of Computerized System Validation (CSV) and experience with electronic QMS systems; knowledge of ISO/IEC 27001 is a plus
Structured, independent working style, analytical mindset, team player and very good German and English skills

Attractive compensation that recognizes your performance
Secure permanent employment with 30 days of annual leave
Opportunity to shape the future within a highly motivated team
Varied tasks with room for your ideas
Job in a future-proof industry—even in turbulent times
Modern offices located in Hamburg or Berlin with good transport connections
Flexible working hours for a healthy work–life balance
Hybrid work model giving you the freedom to choose between office and remote work
Employee offers via Corporate Benefits

Quality and Regulatory Affairs Manager – Medical Devices

Key skills