We have an exciting opportunity for a Regulatory Affairs Specialist to join the team. The client is an established leader in the Medical Device market and operates globally.
- All activities in the area of regulatory affairs
- Support in the maintenance and development of regulatory requirements/documents to ensure the marketing of the product and service portfolio for the implementation of the MDR
- Support in the creation of development-accompanying and technical documentation for new medical devices and the maintenance of existing technical documentation.
- Preparation of registration strategies and registration documents
- Processing, implementation, monitoring and coordination of the approval of medical devices based on the country specifications, e.g. MDR, 510(k),
- Support for correspondence with authorities for inquiries and reports from authorities
- Support of the processes of change management, document control, CAPA, audit and training
- Professional experience in the field of regulatory affairs in medical technology
- Reliability, accuracy and pronounced quality awareness
- Working as a team player and independently in your own tasks
- Very good knowledge of spoken and written German & English
- Experienced handling of IT and standard Office programs