Senior Regulatory Strategist, Medical Devices (Onsite)

Posted yesterday

epm scientificIrvine (CA)

Regulatory Affairs Managers Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Manager

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About the role

EPM Scientific in Irvine, CA is seeking a Senior Regulatory Affairs Specialist to support regulatory strategy, FDA submissions, and lifecycle activities for neurovascular medical devices. This onsite role collaborates with engineering, quality, clinical, and commercial teams to ensure compliance and market access across global regulatory programs. The ideal candidate has 4+ years of device regulatory experience (or an advanced degree with 2+ years) and understands EU MDR, ISO 13485, and ISO

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