Eko Health
Director, Global Regulatory Affairs & Intelligence
Emeryville, CA · Director
Sponsorship not specified$220k-$246kDetected 14 days ago
AlgorithmsMachine LearningComplianceProduct ManagementProduct StrategyClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceMedical DevicesResearchLeadershipCommunicationProblem SolvingRegulatory Affairs
About the role
- 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.
- Eko was named one of the World's Top HealthTech Companies of 2025 by TIME and Statista.
Responsibilities
- 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.
Requirements
- Bachelor's degree in a STEM field (Engineering, Life Sciences, or related discipline)
- Deep expertise in global regulatory frameworks (FDA 510(k)/De Novo, EU MDR, ISO 13485, MDSAP) and demonstrated ability to navigate complex, multi-jurisdictional pathways
- Proven track record managing regulatory authority interactions, including pre-submission meetings, deficiency responses, and regulatory inspections with favorable outcomes
- Strategic regulatory intelligence capabilities with ability to translate emerging requirements (AI/ML regulations, cybersecurity guidance) into actionable business recommendations
- Experience leading small but mighty regulatory teams in fast-paced, innovation-driven environments with rapidly evolving product portfolios
- Proficiency with regulatory information management systems, quality management software (e.g., Veeva Vault, MasterControl, Greenlight Guru), and submission platforms (eSTAR, EUDAMED)
- Strong communication, organizational, and problem-solving skills with ability to influence cross-functional stakeholders and present complex regulatory strategy to executive leadership
- Great track record of successful teaming and contributing meaningfully to company culture
Nice to have
- Advanced degree (MS, PhD, MBA, or RAC) in a relevant scientific, engineering, or regulatory discipline
- Regulatory Affairs Certification (RAC) from RAPS or equivalent professional credential
- Track record securing breakthrough device designations, De Novo classifications, or novel regulatory pathways for first-in-class innovations
- Experience overseeing Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP) to strategically align clinical evidence with global regulatory claims and maximize competitive positioning.
- Experience serving as or managing the requirements for a Person Responsible for Regulatory Compliance (PRRC) under EU MDR 2017/745
- We believe the ability to listen is the ability to care.
Compensation
- $220k-$246k
Benefits
- The opportunity to work on products that impact the health of millions of people.
- Generous paid-time off
- Stock incentive plans
- Medical/Dental/Vision, Disability + Life Insurance
- One Medical membership
- Parental Leave
- Learning and Development stipend
- About Eko Health
- 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.
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This listing is sourced directly from Eko Health's careers page and normalized into a canonical job model.