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.
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: