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Regulatory Affairs Specialist Medical Devices in Gent

In order to supports its activities with Medical Devices, Christeyns is seeking a Regulatory Affairs Specialist for Medical Devices. Originele vacature is te vinden op StepStone.be – Vind gelijkaardige jobs, informatie over werkgevers en carrièretips op StepStone.be!

8 - 40 uur per week

Beschrijving

  • Collaborate in a multi-disciplinary team with Regulatory, Quality, Technical, Marketing, R&D and Production in order to assure compliance with the Medical Devices Regulation.
  • Communicate with the Notified Body for organization audits (re-certification every 5 years and annual follow-up audits) and lead these audits.
  • Organize and coordinate post-market follow-up studies in collaboration with local sales companies
  • Prepare, update and submit technical dossiers of medical devices.
  • Be responsible for reporting incidents with Medical Devices.
  • Cooperate with consultants and laboratories for the generation of tests required for the medical devices registration.
  • Keep informed about Medical Devices legislation and guidance.
     

You are part of the Corporate Regulatory Affairs team and you will be based in Belgium. You will report to the Regulatory Affairs Manager.


  • You have a higher education with knowledge of chemistry (Master).
  • You are communicative and open-minded, a team player.
  • You have good writing skills.
  • Fluent speaking and writing in English is a must.

Extra informatie

Status
Inactief
Opleidingsniveaus
Master
Plaats
Gent
Werkuren per week
8 - 40
Dienstverbanden
Tijdelijke fulltime baan
Beroepsgroepen subcategorie
Metaaltechnisch / Werktuigbouwkundig
Rijbewijs nodig?
Nee
Auto nodig?
Nee
Motivatiebrief verplicht?
Nee
Talen
Nederlands

Gent | Technische vacatures | Tijdelijke fulltime baan | Master