We are looking for a RA/QM Professional with the following qualifications:
- More than 5 years of experience in a regulatory or quality management role in the medical device and/or in vitro diagnostic device industries
- Master degree or higher in Biomedical Engineering or related scientific profession
- Auditor experience with proven qualification according to ISO19011:2018
- Knowledge in the review and implementation of quality management requirements such as EU MDR 2017/745, EU IVDR 2017/746, MDSAP and/or ISO 13485:2016
- Knowledge in the preparation of gap analysis against legal or standard requirements
- Knowledge in the drafting of technical documentation according to the requirements of the EU MDR or EU IVDR
- Knowledge in managing local or international projects with cross-functional teams
- Fluent in English. German language is a plus.
- Excellent presentation skills and communication skills
- Ability to work with a multinational team and to share experience with different level of seniority
- Willing to travel and work across the globe