Director, Global Regulatory Affairs & Intelligence

Eko (4 days ago)

Emeryville, CAOnsiteFull TimeSenior$100,000 - $170,000Regulatory Affairs

About this role

Eko is seeking a Director of Global Regulatory Affairs & Intelligence to lead the company's regulatory strategy for medical devices and SaMD products worldwide. The role involves managing regulatory submissions, ensuring compliance, and fostering innovation through early regulatory engagement. It supports Eko's mission to bring FDA-cleared, AI-powered detection tools to market globally, enhancing patient outcomes.

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Required Skills

Regulatory Strategy
FDA
Ce Mark
Clinical Documentation
Regulatory Submissions
Quality Management
International Regulation
Medical Devices
Regulatory Intelligence
Team Leadership

Qualifications

Bachelor's degree in a STEM field
10+ years of regulatory affairs experience
Experience with Class II medical devices and SaMD
Deep expertise in FDA, EU MDR, ISO 13485, MDSAP

About Eko

ekohealth.com

Eko Health builds digital stethoscopes and clinical software that combine high‑fidelity auscultation with AI‑powered analysis to improve detection of cardiovascular and pulmonary disease. Their devices (including stethoscope/ECG combos) stream, record, and share heart and lung sounds to cloud‑connected apps for telehealth, documentation, and clinician collaboration. Eko’s algorithms—including FDA‑cleared models for murmur detection—support screening and diagnostic decision making, and the platform integrates with clinical workflows to enable remote care and research. Clinicians use Eko to standardize exams, enhance diagnostic confidence, and extend access to cardiac care.

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