About the role

Heartflow seeks a senior leader to own post-market quality activities, overseeing complaint handling, product investigations, and adverse event reporting. You will drive CAPA, regulatory submissions, and PMS, ensuring FDA/EU MDR compliance while guiding a growing team. You will partner with R&D, Clinical, and Regulatory Affairs to embed a quality-first culture and advance AI-enabled device oversight across markets.

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JOB OVERVIEW

Experience level

Manager

Location

Austin, TX

Occupation

Regulatory Affairs Managers

Industry

Electromedical and Electrotherapeutic Apparatus Manufacturing

Posted

yesterday

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