Senior Regulatory Affairs Specialist; Fully Remote
Remote / Online - Candidates ideally in
Yonkers, Westchester County, New York, 10701, USA
Listed on 2026-10-02
Yonkers, Westchester County, New York, 10701, USA
Listing for:
Eko Health, Inc.
Remote/Work from Home
position Listed on 2026-10-02
Job specializations:
-
Healthcare
Job Description & How to Apply Below
- Lead QMS and regulatory remediation to align global procedures with FDA QMSR and ISO 13485.
- Manage global regulatory submissions and interactions with Notified Bodies for EU MDR and other markets.
- Serve as RA representative on core project teams for hardware and AI/software releases.
- Bachelor's or advanced degree in Engineering, Life Sciences, or related field.
- 5-8+ years of progressive regulatory affairs experience in medical devices or digital health.
- Strong knowledge of FDA 21 CFR 820, EU MDR 2017/745, ISO 13485, and global submissions.
- Opportunity to work on products that impact the health of millions.
- Generous paid-time off, stock incentive plans, and comprehensive benefits.
- Mission-driven team with strong venture backing and industry recognition.
Eko Health develops AI-powered digital stethoscopes and ECG tools to help clinicians detect heart and lung disease. The company is venture-backed, recognized by TIME as a top healthtech company, and has a mission-driven team of engineers, physicians, and creatives.
Position Requirements
10+ Years
work experience
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