RA IVD Expert – Zurich

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RA IVD Expert – Zurich


  Zurich   

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This is the opportunity to join a fast growing medical firm based in Zurich as a expert for regulatory in IVD devices. You will be joining an experienced team as an expert within your field learning and communicating with other experts gaining exposure to a variety of different products and devices within the IVD market.

Role Responsibilities:

  • provide regulatory support for IVD and CDx products throughout the full product lifecycle.
  • ensure fulfilment of EU requirements (IVDD/IVDR).
  • compilation of technical documentations relating to IVD’s.
  • collaboration with other regulatory experts surrounding subjects relating to CE marking of IVDs.
  • implementation of quality management systems according to ISO 13485 and MDSAP.

Candidate requirements:

  • Bachelor’s degree or equivalent in natural sciences engineering or equivalent.
  • Several years’ experience in IVD regulatory or quality related positions within IVD or at a notified body.
  • Experienced in CE marking of IVD products and working with QM systems to ISO13485.
  • Practical experience with class A/B products (desirable).
  • Excellent project management skills.