Director, Global Regulatory Affairs & Intelligence

Eko builds AI and digital tools to enable every healthcare provider to more accurately detect heart and lung disease – the leading causes of death globally. Our FDA cleared, industry leading products are used by hundreds of thousands of clinicians on millions of patients around the world. With Eko, clinicians can detect cardiac and pulmonary disease with higher accuracy, diagnose with more confidence, manage treatment effectively, and ultimately give their patients the best care possible.

We have strong venture capital backing from investors like Artis Ventures, Questa Capital, Highland Capital, and Mayo Clinic Ventures.

Recognized by TIME magazine in 2025 as one of the world’s top healthcare technology companies, Eko is one of the fastest growing digital health companies with products used around the world at some of the most prestigious health systems.

We have more than 8 FDA clearances including novel AI algorithms, and we invest heavily in quality clinical research and R&D to build and validate exceptional products for patients we care deeply about.

We’ve built a mission driven, high performing, talented, and diverse team of engineers, physicians, PhD’s, creatives, and technologists. We are committed to investing in each other and our mission to ensure all patients have access to high quality care.

We are headquartered in Emeryville, California and privately-held with world class investors and partners.

This role drives Eko's ability to bring AI-powered cardiac and pulmonary detection tools to market globally by leading regulatory strategy across the full product lifecycle. The Director owns the overall regulatory strategy for the company and drives highly coordinated submissions and approvals (FDA, CE Mark, Health Canada, PMDA, etc.) for our SaMD and hardware portfolio, ensuring accelerated market access while maintaining compliance with evolving requirements like EU MDR and emerging AI regulations. By embedding regulatory intelligence early in product development, this leader enables innovation, mitigates business risk, and unlocks revenue growth across priority geographies transforming novel detection tools into cleared, commercially viable products that improve patient outcomes.

• Proven ability to own and drive end-to-end regulatory strategy from concept through commercialization, including portfolio prioritization and resource allocation aligned with business goals

• Lead and execute regulatory submissions (FDA 510(k)/De Novo, CE Mark, Health Canada, PMDA) for medical device hardware and SaMD products, directly authoring technical documentation and managing agency interactions (e.g., interactive responses and presubmission meetings) to secure timely approvals

• Serve as the regulatory lead for the company, managing all interactions with regulatory authorities including pre-submissions, responses to deficiencies, inspections, and ongoing correspondence

• Partner with cross-functional teams (R&D, Clinical, Quality, Product, Commercial) to define and proactively embed regulatory requirements into product development workflows and align global market access strategies with business priorities

• Collaborate with Head of Quality to ensure the Quality Management System represents state-of-the-art practices and supports regulatory compliance and post-market surveillance programs

• Establish and lead a proactive regulatory intelligence program to monitor evolving global requirements (EU MDR, EU AI Act, FDA SaMD guidance, IMDRF standards), provide and implement strategic recommendations to executive leadership on product roadmap, risk mitigation, and competitive positioning

• Build and mentor a high-performing regulatory team while driving the continuous optimization of internal workflows and submission processes, establishing scalable processes that support rapid portfolio expansion while maintaining compliance excellence

• Ensure compliance with company policies and applicable laws across all regulatory activities, including adverse event reporting, clinical studies and evaluations, and labeling requirements

• Other duties as assigned

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