Senior or Principal Regulatory Affairs Specialist

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.
• 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.

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.