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$127,500 – $178,000
Listed on Oura’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
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. The full posting is on their site.
Skills this role names
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What they ask for
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