Remote Senior Regulatory Affairs Specialist Expansion

Eko Devices; Northern (KY); Hybrid; USD 138,000 - 192,000; Full time

Benefits offered by this job

Generous paid-time off

Stock incentive plans

Medical/Dental/Vision

Disability + Life Insurance

One Medical membership

Parental Leave

401k Matching

Learning and Development stipend

Job summary

Eko Health is pioneering AI-powered cardiovascular care by placing advanced digital stethoscopes, ECG hardware, and FDA-cleared AI algorithms into the hands of clinicians worldwide.

In this pivotal role as Senior or Principal Regulatory Affairs Specialist, you will lead regulatory remediation, oversee global expansion across clinical and veterinary markets, and drive regulatory strategy for software and hardware platforms.

Qualifications

• 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.
• Strong working knowledge of FDA 21 CFR 820 / QMSR, EU MDR 2017/745, ISO 13485, and global regulatory 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.
• Other duties as assigned.

Skills

Regulatory Affairs

Medical Devices

SaMD (Software as a Medical Device)

FDA Regulations (21 CFR 820 / QMSR)

EU MDR

Education

Bachelor’s or Master’s/advanced degree in Engineering, Life Sciences, Regulatory Affairs, or related technical discipline

Job description

Eko Health is pioneering AI-powered cardiovascular care by placing advanced digital stethoscopes, ECG hardware, and FDA-cleared AI algorithms into the hands of clinicians worldwide.

In this pivotal role as Senior or Principal Regulatory Affairs Specialist, you will lead regulatory remediation, oversee global expansion across clinical and veterinary markets, and drive regulatory strategy for software and hardware platforms.