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.
- 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.
- 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.