Support and further develop the quality management system according to 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 reporting and communication with authorities
Handling CAPA, non‑conformities and customer complaints, and tracking corrective and preventive actions
Support planning, execution and follow‑up of internal and external audits as well as supplier qualification
Assist in the validation of computerized systems (CSV), including risk analysis, test planning, execution and documentation

Degree in a scientific or technical field (e.g., biomedical engineering, engineering, life sciences, quality management) or equivalent qualification
At least 2 years of relevant professional experience in Quality Management and/or Regulatory Affairs within 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; knowledge of ISO/IEC 27001 is a plus
Structured, independent working style, analytical thinking, team spirit, and very good German and English skills

Quality and Regulatory Affairs Manager – Medical Devices

Key skills