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  • Locatie

    Amersfoort, Amersfoort, Utrecht

  • Functie titel:

    Senior Regulatory Affairs Specialist

  • Sector:

  • Job ref:

    46210

  • Start datum:

    2021-05-25

The Company 
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. 

Role Description
You'll represent the client in various internal forums, Trade Associations and also meetings with local Health Authorities/Competent Authorities. 

Responsibilities 
Managing specific regulatory requirements regarding Medical Devices and Drug distribution
- Review and approval of promotional materials 
- Review and update of processes and procedures linked to all relevant Regulatory Affairs activities
- Identify regulatory issues and report them to Management
- Investigate and suggest  solutions to resolve them 
- Ensure all post marketing regulatory requirements are met


Requirements 
- Bachelor or Master Degree in pharmacy, medicine, engineering or science
- 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 Ece Karakurt at e.karakurt@sire-search.com or +31 (0) 20 658 98 01
Neem contact op

SIRE® LIFE SCIENCES B.V.

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

SIRE® STAFFING SOLUTIONS B.V.

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