Senior SaMD & IVD Quality Leader

A global biopharmaceutical leader seeks an experienced SaMD and IVD Principal Manager to oversee device quality activities across the product lifecycle, ensuring compliance with international regulations and providing quality oversight for regulatory filings. You will lead quality initiatives and support clinical development efforts, making critical decisions under uncertainty. Candidates should have a Bachelor's degree in Engineering and at least 5 years of relevant experience, particularly in the medical device industry.

This is a full-time role based in Lexington, MA.
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