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. Backed by venture capital investors such as Artis Ventures, Questa Capital, Highland Capital, and Mayo Clinic Ventures, Eko was recognized by TIME magazine in 2025 as one of the world’s top healthcare technology companies. We have more than eight FDA clearances, including novel AI algorithms, and invest heavily in quality clinical research and R&D. Our mission‑driven, high‑performing, diverse team includes engineers, physicians, PhDs, creatives, and technologists dedicated to ensuring all patients have access to high‑quality care.
Role Summary
As a 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.
Responsibilities
- 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.
Requirements
- 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.
- Strong communication, organizational, and problem‑solving skills.
- Ability to perform the essential functions of the role with or without reasonable accommodation.
Preferred Qualifications
- RAC (Regulatory Affairs Certification) preferred.
- Experience in a startup or high‑growth environment.
Benefits
- Opportunity to work on products that impact the health of millions of people.
- Generous paid‑time off.
- Stock incentive plans.
- Medical, Dental, Vision, Disability, and Life Insurance.
- One Medical membership.
- Parental leave.
- 401(k) matching.
- Learning and Development stipend.
Pay
Compensation is determined using a tiered market‑based structure. Tier 1: $172,683.45 – $192,999.15; Tier 2: $155,415.11 – $173,699.24; Tier 3: $138,146.76 – $154,399.32 (ranges vary by location, experience, skills, and qualifications).
Work Experience & Location
- Remote position with expected travel.
- Prolonged periods of sitting and working at a computer.
- Must be able to perform job duties with or without reasonable accommodation.