# Senior Regulatory Affairs Specialist

Hiring organization: [Oura](https://career.thegoodapps.co/organizations/oura)

Canonical page: https://career.thegoodapps.co/jobs/223e1973-20c0-4699-aec4-a0c3ceb23f9b

Listed on Oura's own careers site. Applications go to them directly.

- Seniority: Senior
- Location: Remote - United States
- Remote: yes
- Salary: 127500 – 178000 USD per year

## Summary

This role supports regulatory strategy and operations for Oura's software medical devices, handling submissions, documentation, compliance tracking, and cross-functional coordination throughout the product lifecycle. It suits experienced regulatory professionals with a background in medical devices or digital health who thrive managing complex documentation and approval processes in a growing company.

_Our summary, not Oura's wording._

## Skills named

Document Control, ISO 13485

## Required

- Bachelor's degree in science, engineering, healthcare, or related field
- 5+ years regulatory affairs or operations experience in medical devices, digital health, or regulated healthcare
- Experience with software-based medical products or SaMD
- Knowledge of FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971
- Experience compiling and maintaining regulatory documentation in controlled environments
- Project coordination and document management skills
- Strong written and verbal communication

## Nice to have

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

Apply on Oura's site: https://job-boards.greenhouse.io/oura/jobs/4363806009