Senior Regulatory Affairs Specialist

📋 Description

• Lead regulatory and quality strategies for product development, approvals, launches, and lifecycle
• Support regulatory operations for SaMD products throughout development, submission, launch, and
• Coordinate preparation, compilation, publishing, submission, and archival of regulatory
• Maintain accurate regulatory records, including submission trackers, registrations/listings
• Assess regulatory impact of software updates, labeling changes, and other product modifications.
• Track milestones, renewals, commitments, and post-market reporting requirements.

🎯 Requirements

• Bachelor’s degree in a scientific, engineering, healthcare, or related discipline.
• 5+ years in regulatory affairs/operations within medical devices, digital health, or other
• Hands-on experience supporting software-based medical products or SaMD.
• Working knowledge of FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, ISO 14971.
• Experience compiling regulatory documentation in a controlled environment.
• Strong project coordination, organization, documentation, and deadline-management skills.

🎁 Benefits

• Competitive salary and equity packages.
• US market-based compensation determined by location, skills, experience, qualifications, internal
• Region 1: $151,300–$178,000.
• Region 2: $138,550–$163,000.
• Region 3: $127,500–$150,000.
• Health, dental, and vision insurance.