Director, Clinical Quality & Compliance: Regulatory Leader

Posted yesterday

heartflowBrooklyn (NY)

Regulatory Affairs Managers Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Manager

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About the role

Heart Flow, Inc. seeks a Director of Clinical Quality & Compliance to provide strategic oversight of QA and regulatory programs across pre- and post-market research initiatives. You will ensure GCP, IDE, and labeling standards are followed, while coordinating with Clinical Operations and CROs to maintain inspection readiness. You will guide monitoring, ICF/IBs/IFUs, and safety reporting, overseeing audits and CAPA processes to sustain high-quality, compliant clinical trials globally.

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