Senior Regulatory Affairs Specialist

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $138.1k - $193k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Eko Health

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

Eko Health is a company specializing in digital and AI-powered stethoscopes and health solutions. Their products, such as the Eko CORE 500™ and Eko DUO, integrate digital stethoscope technology with artificial intelligence to enhance the detection of cardiovascular diseases, including murmurs, atrial fibrillation, and heart failure. Eko's technology is utilized in telehealth settings, life sciences partnerships, and for health systems globally, providing enhanced clinical insights through acoustic and cardiac examination tools. Their solutions aim to improve the standard of care by providing better diagnostic insights during auscultation, supporting clinicians in making more accurate and confident health assessments.

📋 Description

• 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