Currently, I am looking for a Regulatory Manager for one of our Medical Device clients in the Utrecht area. The organisation is a developer, manufacturer and supplier of diabetes care devices. Their goal is improving healthcare on an global level.
- Completely involved with creating strategies and developing plans to make sure that products are compliant when it comes to required documentation and legislation
- Leading various types of audits among which internal, and distributor audits
- Lead the team in acting up on these audits, performing CAPA’s and creating tools for compliancy
- Internal and external audits for the Quality Management System at international locations
- You will be the Quality point of contact the establishment and maintenance of relationships with internal and external authorities.
- Bachelor of Life Sciences or related
- Minimal 3 years of experience within Medical Devices
- Proven experience in building and maintenance of relationships with internal and external authorities
- In-depth knowledge of MDR, MDD and FDA
- Fluent in English and Dutch
- Team player and good communicator
INTERESTED? Please contact for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org