Senior Regulatory Affairs Specialist (SaMD)

Location: Remote - United States. Candidates residing in Alaska, Delaware, Iowa, Mississippi, Nebraska, South Dakota, West Virginia, or Wisconsin are not being considered.

Salary: $151,300–$178,000 for Region 1; $138,550–$163,000 for Region 2; $127,500–$150,000 for Region 3. Pay tier depends on US work location.

Company

hirify.global develops the Oura Ring and connected app to provide health, readiness, activity, and sleep insights.

What you will do

• Lead regulatory and quality strategy for product development, approvals, and lifecycle management of wellness and regulated features.
• Support regulatory operations for Software as a Medical Device products across development, submission, launch, and post-market phases.
• Coordinate the preparation, compilation, publishing, archival, and maintenance of regulatory submissions and correspondence.
• Maintain submission trackers, product registrations, regulatory commitments, approval records, and change assessment logs.
• Support software change assessments, UDI and market-access maintenance, and evaluation of regulatory filing impacts.
• Prepare regulatory evidence for inspections and audits, monitor relevant regulations and standards, and improve scalable regulatory processes and tools.

Requirements

• Bachelor’s degree in a scientific, engineering, healthcare, or related discipline.
• 5+ years of regulatory affairs or regulatory operations experience in medical devices, digital health, or regulated healthcare products.
• Hands-on experience supporting software-based medical products or SaMD.
• Familiarity with FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971.
• Experience maintaining controlled regulatory documentation, with strong project coordination, organization, communication, and document management skills.
• Ability to manage multiple priorities and deadlines with strong attention to detail.

Nice to have

• Experience supporting 510(k), De Novo, technical documentation, or international registrations.
• Familiarity with eQMS, document control, and submission management tools.
• Experience with software change assessments, traceability, lifecycle documentation, cybersecurity, labeling, and post-market requirements for SaMD.
• RAC certification or other relevant regulatory training.
• Experience in a fast-paced startup or high-growth medtech environment.

Culture & Benefits

• Health, dental, vision, and mental health resources.
• Oura Ring and employee discounts for friends and family.
• 20 days of paid time off, 13 paid holidays, and 8 days of flexible wellness time off.
• Paid sick leave and parental leave.
• Competitive salary and equity packages.