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. Qualifications: 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. Why Join Eko Health: 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 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. #J-18808-Ljbffr
Senior Regulatory Affairs Specialist (Fully Remote) in workfromhome at Unknown Company
This position is listed as full time and onsite.