Academic education in Sciences /Engineering
/Biotechnology/Electronics/Software etc
Proven experience in IVDs and LDTs for Medical Deviceproducts
Profound understanding of ISO 15189, ISO 13485,
21CFR820, EU-IVDR and other relevant standards and
regulations as well as the V&V tests
Advantage: experience with submissions to FDA and/or
Europe
Capabilities to work with customers, self-learning
manage projects and perform tasks with a high level of
professionalism and responsiveness