Jobs in life sciences

IVD compliance expert (senior)

Ref. IVDE
Function: Support on analytical performance, clinical performance and scientific validity in relation to the IVD regulation (IVDR).
Location: Geel

The company:

The company is a fast-growing company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Their objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. They help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). They are also authorized representatives for non-EU manufacturers and offer a unique solution for e-labeling, currently used by multi-billion-dollar medical device and IVD companies.

From their offices in Geel, Eindhoven, Turin and other international sites, they serve more than 200 customers worldwide.

Job description:

As part of a multi-functional team, you will contribute to our customers’ compliance and facilitate the market introduction of their IVD. 

Support on analytical performance, clinical performance and scientific validity in relation to the IVD regulation (IVDR). Good with text and (clinical) data.

Your tasks will include, depending on your experience:

  • Review of technical documentation of IVD assays.
  • Review of product labeling.
  • Give manufacturers feedback on the quality of their assay’s verification and validation data.
  • Writing of technical documentation, including performance evaluation plans and reports, (analytical and clinical performance reports).
  • Assist manufacturers in the performance of risk assessment and in the identification of regulatory requirements.
  • Assist colleagues in the preparation and follow-up of performance evaluation studies.
  • Interact with international customers on the points above.

Requested competences and skills:

  • Holding a university degree in biology, biochemistry, bioengineering, biomedical sciences or pharmacy. 
  • Experience in an IVD company, clinical laboratory or test laboratory is an important advantage. 
  • Experience with IVD assay development or validation is an important advantage. 
  • Strong analytical skills and an eye for detail. 
  • Good writing skills in the English language. 
  • Enjoys working in an international context. 
  • Eager to learn. 
  • Likes variation in handling several projects at the same time and understands that working in a small team requires a flexible attitude.
  • A minimum of 5 years of experience in an IVD company, clinical laboratory or similar environment. We welcome applications of candidates with a longer track record in this field.
  • Understanding analytical and clinical performance of an IVD assay is a must.
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