Amersfoort, Amersfoort, Utrecht
Senior 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.
You'll represent the client in various internal forums, Trade Associations and also meetings with local Health Authorities/Competent Authorities.
- 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
- 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
For more information please contact Ece Karakurt at email@example.com or +31 (0) 20 658 98 01