Support and further develop the quality management system in accordance with DIN EN ISO 13485 and the EU AI Act
Support 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 incident reporting and communication with authorities
Handle CAPA, nonconformities and customer complaints, and follow up on corrective actions
Support planning, execution and follow-up of internal and external audits as well as supplier qualification
Assist with validation of computerized systems (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 technology
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 working with CAPA, complaint handling and audit preparation
Knowledge of Computerized System Validation (CSV) and experience with electronic QMS; knowledge of ISO/IEC 27001 is a plus
Structured, independent working style, analytical thinking, team spirit, and very good German and English language skills

Attractive remuneration that recognizes your performance
Secure, permanent employment with 30 days of paid vacation
Opportunity to help shape the future in a highly motivated team
Varied tasks with room for your ideas
Role in a future-proof industry — even in turbulent times
Modern offices in Hamburg or Berlin with good transport connections
Flexible working hours for a balanced work–life situation
Hybrid working model that gives you the freedom to choose between office and remote work
Employee offers via Corporate Benefits

Quality and Regulatory Affairs Manager – Medical Devices

Key skills