Medical Devices
Medical Devices

Regulatory Affairs Specialist

Belgium, Zaventem

Scope

Fantastic opportunity to join a global manufacturer of innovative market leading medical devices, an organisation that have been at the forefront of the coronavirus pandemic and continue to grow their teams at a rapid rate.

Responsibilities

  • Handle and maintain EU notifications.
  • Handle and maintain registrations in non-EU countries within EMEA.
  • Review technical documentation and promotional material.
  • Address regulatory requests from the distributors, dealers, sales, and marketing.
  • Maintain database of valid current documentation of products from all division including CE, ISO 13485, DoC, labelling, GMDN, IFU-User Manual, etc.
  • Maintain network drive and SharePoint platform.
  • Give support in any other areas deem necessary on daily basis or whenever required.
  • Participate in regulatory meetings and take the ownership of regulatory actions.

About You

  • Previous experience in regulatory affairs.
  • Knowledge of pharmaceutical and/or medical devices regulatory affairs is a plus.
  • Modest working knowledge of MS office is a must.
  • Knowledge of SharePoint and Agile is a plus.
  • Generic science understanding
  • Lab experience
  • Degree in related subjects – i.e., health sciences
  • Master’s Degree – Ideal
  • Good knowledge of English and French – reading, writing, speaking – is a must.
If you are interested in the above role then please apply or get in touch to discuss further.
Elliott Firth Managed by Elliott Firth
highlights
International
Permanent
Office
apply Posted - 11.02.2021

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