Regulatory Affairs and Quality Assurance Consultant Medical Devices - Germany
We want to expand our multi-functional team with a QA/RA professional with considerable experience in the Medical Device field to assist our medical device customers in meeting regulations and standards. Your tasks will include:
- Help in the identification of regulatory requirements, including standards.
- Assist in the interpretation of regulatory requirements and standards and translate them into practical specifications and project requirements
- Guide customers through the entire regulatory process
- Write or review procedures related to requirements of standards and regulations
- Preferably also assist the customer with the implementation of a quality system in agreement with ISO13485.