Senior Regulatory Affairs Specialist

📋 Description

• Lead architectural QMS and regulatory remediation, aligning global procedures into unified
• Revise and consolidate SOPs for Design History File (DHF), Design and Development Files
• Drive regulatory documentation cleanup and maintain the Global Regulatory Submissions &amp
• Inform global registration strategies and submission execution across EU (MDR), UK (UKCA/SGS
• Manage interactions with Notified Bodies and EU Authorized Representatives for technical file
• Support regulatory evaluation and intelligence mapping for Eko Vet+ rollout across global

🎯 Requirements

• Bachelor’s or Master’s/advanced degree in Engineering, Life Sciences, Regulatory Affairs, or
• 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
• Direct experience writing/submitting 510(k)s, Q-Subs, De Novo, Technical Files, and managing
• Proven track record leading major QMS remediation programs and global market entries.
• Strong communication, organizational, and problem-solving skills.

🎁 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