Regulatory expert for IVD In-Vitro Diagnostics JB-236

ישראל, צפון

תיאור המשרה

Responsible for review and maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.

דרישות המשרה

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
This position is open to all candidates.

הערות נוספות

המשרה מיועדת לגברים ולנשים כאחד

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