Senior Regulatory Affairs Specialist (SaMD)

TL;DR

Senior Regulatory Affairs Specialist (SaMD): Support regulatory operations for Software as a Medical Device portfolio across the product lifecycle with an accent on submission support, document management, change assessments, and compliance activities. Focus on coordinating FDA and EU submissions, maintaining regulatory documentation, and ensuring inspection readiness in a fast-paced environment.

Location: Remote - United States, strong preference for the East Coast. Not considering candidates in AK, DE, IA, MS, MO, NE, SD, VT, WV, WI.

Salary: $127,500 - $178,000 (depending on US region/tier).

Company

Oura develops award-winning wearable products like the Oura Ring and app to provide insights on sleep, activity, and health readiness for millions of users worldwide.

What you will do

• Support regulatory operations for SaMD products across development, submission, launch, and post-market phases.
• Coordinate preparation, compilation, publishing, and archival of regulatory submissions and correspondence.
• Maintain regulatory documentation including submission trackers, registrations, commitments, and change logs.
• Partner with leads on FDA, EU, and global market activities; manage health authority requests and deadlines.
• Conduct design change assessments for software updates, labeling, and modifications to determine filing impacts.
• Contribute to inspection/audit readiness and monitor evolving SaMD regulations to translate into actions.
• Collaborate cross-functionally to improve regulatory processes, templates, and tools for efficiency.

Requirements

• Bachelor’s degree in scientific, engineering, healthcare, or related discipline.
• 5+ years in regulatory affairs or operations for medical devices, digital health, or regulated healthcare products.
• Experience supporting software-based medical products or SaMD.
• Familiarity with FDA requirements, EU MDR, ISO 13485, IEC 62304, ISO 14971.
• Experience compiling/maintaining regulatory documentation in controlled environments.
• Strong project coordination, organization, document management, communication skills, and attention to detail.

Nice to have

• Experience with 510(k), De Novo, technical documentation, or international registrations.
• Familiarity with eQMS, document control, submission tools.
• Software change assessments, traceability, cybersecurity, labeling, post-market for SaMD.
• RAC certification or relevant training; fast-paced startup/medtech experience.

Culture & Benefits

• Competitive salary, equity, health/dental/vision insurance, mental health resources.
• Oura Ring provided plus employee discounts.
• 20 PTO days, 13 holidays, 8 flexible wellness days, paid sick/parental leave.
• Collaborative, passionate culture; offices in SF, San Diego, LA; informal gatherings in other cities.