Our client is a Medical Devices Company located Rotterdam, The Netherlands. The company is active in three different product classifications: Medical Devices, Cosmetics and Foods.
As Regulatory Affairs Specialist you will be part of a global team that has the responsibility to set the regulatory strategy for compliance of the product portfolios. The emphasis of this role will lie on the clinical evaluation compliance (medical device) with related
standards and regulations and will require close collaboration with the Medical Affairs team to set the pre-clinical, clinical and post marketing follow-up strategies to plan the work.
- Project management & ownership: project participation and milestone delivery
- Design change to DHF for new product development as well as in change controls and update technical files
- Assuring ISO and EC compliance upon development and change
- Assure RA communication for product development/design change and RA evaluation/ submission
of change to notified bodies.
- Assuring technical documentation for stability protocol and report
- Ensuring appropriate production from lab scale to commercial scale including validation and qualification in close collaboration with QA team.
- International registration by compiling of DHF of medical devices.
- Bsc or up (preferably in Life Sciences)
- Minimum of 3 years experience in a quality role
- Knowledge in MDD/MDR and ISO13485. FDA regulation knowledge is a plus.
- Fluent in English (Dutch considered a big plus)
- Willing and able to work on site for at least 1 day per week