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

Note:

Job duties may change at any time with or without notice. Required Qualifications Bachelor's degree in a STEM field (Engineering, Life Sciences, or related discipline); advanced degree preferred 10+ years of progressive regulatory affairs experience with Class II medical devices and Software as a Medical Device (SaMD), including hands-on submission authorship and successful FDA and international approvals (must provide specific K numbers) 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 Ability to perform the essential functions of the role with or without reasonable accommodation Preferred Qualifications Advanced degree (MS, PhD, MBA, or RAC) in a relevant scientific, engineering, or regulatory discipline Experience with AI/ML-enabled medical devices and familiarity with FDA's Software Pre-Cert Program, AI/ML guidance, and algorithm change protocols Regulatory Affairs Certification (RAC) from RAPS or equivalent professional credential Direct experience in digital health, cardiovascular diagnostics, or acoustic/sensor-based medical technologies Track record securing breakthrough device designations, De Novo classifications, or novel regulatory pathways for first-in-class innovations Experience navigating reimbursement considerations and engaging with health economics teams to support regulatory strategy and claims development Background in early-stage or high-growth medtech startups with demonstrated ability to build regulatory infrastructure from the ground up Experience serving as or managing the requirements for a Person Responsible for Regulatory Compliance (PRRC) under

EU MDR 2017/745

Experience overseeing Clinical Evaluation Reports (CER) and Clinical Evaluation Plans (CEP) to strategically align clinical evidence with global regulatory claims and maximize competitive positioning. Why join Eko Health?

Benefits and Perks We Offer:

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 401k Matching Learning and Development stipend We believe the ability to listen is the ability to care. Eko was named one of the World's Top HealthTech Companies of 2025 by TIME and Statista. This honor reflects the mission to transform cardiac and pulmonary care through AI-powered stethoscopes and digital health solutions. Case Studies & Customer Stories Eko Blog Newsroom Work Experience & Location Requirements This role is based out of our office in Emeryville, CA This is a Hybrid role (In-Office days are Tuesday, Wednesday and Thursday) Prolonged periods of sitting and working at a computer Must be able to perform job duties with or without reasonable accommodation $220,000 - $246,000 a year Compensation for this role is determined using a tiered, market-based compensation structure that reflects the cost of labor across different U.S. geographic locations. Salary ranges are established based on geographic labor market data and may vary depending on the employee's work location, as well as job-related knowledge, skills, qualifications, 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. 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Director, Global Regulatory Affairs & Intelligence