Regulatory Affairs Specialist
Our client is an international organization in the Medical Devices (MD) industry with a variety of products such as orthopaedics, vision, interventional solutions and surgery.
As a Regulatory Affairs specialist you will ensure compliance with local regulatory requirements, national and international guidelines.
- Review and approval of Labels and Instructions for Use.
- Update of RA database.
- Handle all necessary activities for the release of SKU (codes) restrictions.
- Ensure regulatory compliance of MD for their access to the Benelux market.
- Identify Regulatory Issues & strategies concerning MD, in the scope of the Project, investigate and suggest solutions to resolve them.
- Provide regulatory support to ensure consistent collaboration with franchises and EMEA/ Regulatory Affairs.
- MSc in Pharmacy, Biomedical Engineering or similar.
- Similar work experience
- Advanced user of Excel
- Excellent communications skills in Dutch and English
For more information please contact Ece Karakurt at firstname.lastname@example.org or +31 (0) 20 658 98 01.