Amersfoort, Amersfoort, Utrecht
Regulatory Affairs Specialist
Our client is an international organization in the Pharmaceutical and Medical Devices (MD) industry with a variety of products such as orthopaedics, vision, interventional solutions and surgery.
As a Regulatory Affairs Specialist you will be the primary internal and external point of contact within the Benelux for all operational regulatory Affairs needs.
- Pre-regulatory authorization
- Management of specific regulatory requirements regarding Medical Devices and Drug distribution
- Identify regulatory issues concerning MD and resolve them
- Oversight and management of company license or registration for MDs, Human Tissue products and Drugs.
- Review and approval of promotional materials
- Review and approval of labelling of MDs and Drugs in local language
- Performing regulatory training for marketing, MD sales representative and other relevant employees
- Review and update of processes and procedures
- Ensure all post marketing regulatory requirements are met, with an emphasis on ensuring all external communication/marketing materials
- BSc or MSc in pharmacy, medicine or biomedical engineering
- Min. 5 years of experience in medical device and/or medicines regulatory affairs
- Fluent in English and Dutch. French is a plus
For more information please contact Carla Garcia at firstname.lastname@example.org or +31 (0) 20 658 98 01.