Regulatory Affairs Officer | GenomeWeb

Regulatory Affairs Officer

Multiplicom NV
Job Location
Galileïlaan 18
2845 Niel

Multiplicom offers a competitive compensation and benefits package, and strong leadership commitment to individual learning and personal development in an entrepreneurial environment.

Job Description
  • Follow-up on new regulations and CE/IVD registration requirements within and outside Europe

  • Preparation of product technical files (STED) in collaboration with R&D

  • Assist Sales team in delivering required information for creating a country specific registration dossier

  • Write and maintain procedures related to registration activities in the Quality System

  • Assist R&D team in delivering required information for all regulatory aspects of performance evaluation studies (clinical RA)

  • Academic degree in life sciences or equivalent by experience

  • Experience as RA Officer or equivalent in a medical device or in vitro diagnostic company working under ISO-13485

  • Sense for responsibility, can work independently and are eager to learn

  • Fluent in English

  • A team player and have good communication skills

How to Apply

Please send applications (English) with CV (including references when available) to Sophie Snijders at

About Our Organization

Multiplicom N.V. is a Belgian biotech company focused on human molecular diagnostics. The company develops, manufactures and commercializes leading edge and easy-to-use genetic test kits based on the latest molecular diagnostic technologies. With its easy and reliable methodology it is enabling all molecular laboratories the implementation of personalized medicine. Multiplicom is located in Niel, and Ghent, Belgium. Please visit for more information.

 Multiplicom considers people its most valuable asset. Each member of our organization makes an essential contribution to our success and the growth of our company. Our culture allows our people to flourish both as professionals and as individuals. Want to join the Multiplicom team? Apply today!

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