Senior Regulatory Affairs Specialist
E
Eko HealthDigital Health
Remote, USFull-TimeSenior
Salary$138,000 - $192,000 a year
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Job Details
- Experience
- 5–8+ years
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, and ISO 13485.
- Direct experience writing/submitting 510(k)s, Q-Subs, De Novo, and Technical Files.
- Proven track record leading major QMS remediation programs and global market entries.
- Ability to manage Notified Body reviews.
- Strong communication, organizational, and problem-solving skills.
- Ability to perform essential job functions with or without reasonable accommodation.
Responsibilities
- Lead architectural QMS and regulatory remediation, aligning global procedures into unified, streamlined workflows.
- Revise and consolidate SOPs for Design History File (DHF), 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.
- Evaluate and implement Regulatory Information Management Systems (RIMS) and AI-native workflows.
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