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  • Locatie

    Amersfoort, Amersfoort, Utrecht

  • Functie titel:

    Regulatory Affairs Specialist

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The Company 
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. 

Role Description 
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 

Other Information 
For more information please contact Carla Garcia at or +31 (0) 20 658 98 01. 
Neem contact op


Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800


Keizersgracht 440A
1016 GD Amsterdam
The Netherlands
+31 (0) 20 658 9804