This is what awaits you:

- Preparation, creation, and maintenance of technical documentation

- Further development of risk management

- Support of digitalization projects

- Support and training of specialist departments in fulfilling regulatory requirements

- Close communication with the responsible regulatory authorities and notified bodies

- Monitoring and communication of regulatory changes

- Maintenance and strategic development of the quality management system

- Support of complaint management, including root cause analysis.

This is what we expect from you:

- Training as a technician (m/f/d), university degree in medical technology, or comparable qualification

- Several years of professional experience in regulatory affairs or quality management at a medical device manufacturer

- Good knowledge of ISO 13485 and ISO 14971

- Good knowledge of the MDR, especially regarding technical documentation

- Optional further training as a QMF (m/f/d)/QMB (m/f/d)

- Reliable, systematic, and independent work style

- Resilient team player (m/f/d) with a high degree of initiative

- Very good knowledge of MS Office products

1. - Good written and spoken English skills.