Senior Regulatory Affairs Specialist
New
J
JobgetherMedical Devices
Based in United StatesFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 5–8+ years
Requirements
- Bachelor’s or Master’s degree in Engineering, Life Sciences, Regulatory Affairs, or a 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 submission requirements.
- Direct experience preparing and submitting 510(k)s, Q-Subs, De Novo submissions, and Technical Files.
- Experience managing Notified Body reviews and international regulatory interactions.
- Proven track record leading major QMS remediation programs and global market-entry initiatives.
- Ability to collaborate effectively with technical, clinical, quality, and commercial stakeholders.
- Strong communication, organizational, analytical, and problem-solving skills.
- RAC certification is preferred.
- Experience working in a startup or high-growth environment is preferred.
Responsibilities
- Lead QMS and regulatory remediation initiatives, aligning global procedures into unified and streamlined workflows.
- Revise and consolidate SOPs covering Design History Files, Post-Market Surveillance, Labeling/UDI, EUDAMED, and global strategy.
- Support compliance with FDA QMSR and ISO 13485 requirements.
- Drive regulatory documentation cleanup and maintain the Global Regulatory Submissions & Deficiencies Database.
- Develop and execute regulatory strategies and submissions across the EU, UK, Canada, APAC, and LATAM markets.
- Manage interactions with Notified Bodies and EU Authorized Representatives.
- Serve as the Regulatory Affairs representative on cross-functional teams supporting hardware and AI/software releases.
- Standardize claims matrices, IFU restrictions, and advertising and promotional review processes.
- Evaluate and implement Regulatory Information Management Systems and AI-enabled regulatory workflows.
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