Senior Regulatory Affairs Specialist
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Job Description
Senior Regulatory Affairs Specialist advancing regulatory strategy for Eko Health’s FDA-cleared AI stethoscopes, ECG hardware, and digital health platforms. Leading QMS remediation and global market submissions.
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
- Perform 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
- RAC (Regulatory Affairs Certification) preferred
- Experience in a startup or high-growth environment
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
- 401k Matching
- Learning and Development stipend
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