Director, Global Regulatory Affairs & Intelligence

Posted:
2/10/2026, 2:10:12 AM

Location(s):
California, United States ⋅ Emeryville, California, United States

Experience Level(s):
Expert or higher ⋅ Senior

Field(s):
Legal & Compliance

Workplace Type:
On-site

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.
Compensation is market-based and reflects the cost of labor across different U.S. geographic locations. The specific salary is based on several factors, including market location, and may vary depending on job-related knowledge, skills, and experience.

Eko is proud to be an equal opportunity employer and welcome people of different backgrounds, experiences, abilities and perspectives. We are committed to building a diverse and inclusive team.

Eko

Website: https://www.ekohealth.com/

Headquarter Location: Emeryville, California, United States

Employee Count: 101-250

Year Founded: 2013

IPO Status: Private

Last Funding Type: Grant

Industries: Artificial Intelligence (AI) ⋅ Health Care ⋅ Health Diagnostics ⋅ Machine Learning ⋅ Medical Device ⋅ mHealth ⋅ Software