Senior Regulatory Affairs Specialist

📋 Description

• Lead QMS and regulatory remediation initiatives, aligning global procedures into unified and
• Revise and consolidate SOPs covering Design History Files, design and development documentation
• Support compliance with FDA QMSR and ISO 13485 requirements.
• Drive regulatory documentation cleanup and maintain the Global Regulatory Submissions &amp
• Develop and execute regulatory strategies and submissions across the EU, UK, Canada, APAC, and
• Manage interactions with Notified Bodies and EU Authorized Representatives for technical file

🎯 Requirements

• Bachelor’s or Master’s degree, or other advanced degree, in Engineering, Life Sciences, Regulatory
• 5–8+ years of progressive regulatory affairs experience in medical devices, digital health, and/or
• Strong working knowledge of FDA 21 CFR 820/QMSR, EU MDR 2017/745, ISO 13485, and global regulatory
• Direct experience preparing and submitting 510(k)s, Q-Subs, De Novo submissions, and Technical
• Experience managing Notified Body reviews and international regulatory interactions.
• Proven track record leading major QMS remediation programs and global market-entry initiatives.

🎁 Benefits

• Fully remote position within the United States, with expected travel.
• Generous paid time off.
• Stock incentive plan.
• Medical, dental, and vision insurance.
• Disability and life insurance.
• One Medical membership.