Senior Regulatory Affairs Specialist

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. 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. Role Summary Eko Health is pioneering AI-powered cardiovascular care by placing advanced digital stethoscopes, ECG hardware, and FDA-cleared AI algorithms into the hands of clinicians worldwide. In this pivotal role as Senior or Principal Regulatory Affairs Specialist, you will support business objectives by leading high-impact regulatory remediation, overseeing global international expansion across clinical and veterinary markets, and spearheading regulatory strategy for cutting-edge software and hardware platforms. Essential Functions - Lead architectural QMS and regulatory remediation, aligning global procedures into unified, streamlined workflows. - Revise and consolidate SOPs for Design History File (DHF), Design and Development Files, Post-Market Surveillance (PMS), Labeling/UDI, EUDAMED, and global Regulatory Strategy to conform with FDA QMSR and ISO 13485. - Drive regulatory documentation cleanup and maintain the Global Regulatory Submissions & Deficiencies Database.

- Inform global registration strategies and submission execution across EU (MDR), UK (UKCA/SGS transition), Canada, APAC, and LATAM markets. - Manage interactions with Notified Bodies and EU Authorized Representatives for technical file reviews, Notifications of Change (NoC), and DoC/CE updates. - Support regulatory evaluation and intelligence mapping for Eko Vet+ rollout across global territories. - Serve as the RA representative on core project teams for hardware and AI/software releases. - Standardize claims matrices, IFU restrictions, and advertising/promotional review processes across commercial and life science units. - Evaluate and implement Regulatory Information Management Systems (RIMS) and AI-native workflows. - Ensure compliance with company policies and applicable laws. - Other duties as assigned. Note: Job duties may change at any time with or without notice. Required Qualifications - Bachelor’s or Master’s/advanced degree in Engineering, Life Sciences, Regulatory Affairs, or related technical discipline. - 5–8+ years of progressive regulatory affairs experience in medical devices, digital health, and/or SaMD (Software as a Medical Device). - Strong working knowledge of FDA 21 CFR 820 / QMSR, EU MDR 2017/745, ISO 13485, and global regulatory submissions. - Direct experience writing/submitting 510(k)s, Q-Subs, De Novo, Technical Files, and managing Notified Body reviews. - Proven track record leading major QMS remediation programs and global market entries.