Senior Regulatory Affairs Lead SaMD and Hardware; Remote
Columbus, Franklin County, Ohio, 43224, USA
Listed on 2026-09-18
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IT/Tech
Eko Health is pioneering AI-powered cardiovascular care. This Senior/Principal Regulatory Affairs Specialist role leads high-impact remediation, global expansion across clinical and veterinary markets, and regulatory strategy for software and hardware platforms.
You will drive QMS remediation, update DHF/DSF, PMS, labeling, and EUDAMED, and guide submissions across EU MDR, UKCA, Canada, APAC, and LATAM. A strong FDA/EU background and 5–8+ years are required.
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