Senior Regulatory Affairs Specialist

We have offices in San Francisco, San Diego and Los Angeles for those who prefer hybrid or office settings. Oura employees in other major cities (like Boston and New York) occasionally gather informally at local co-working locations. US based role, strong preference for the East Coast.

We are seeking a Senior Regulatory Affairs Specialist to support regulatory operations for our Software as a Medical Device (SaMD) portfolio. This role will help drive compliant and efficient execution of regulatory activities across the product lifecycle, including submission support, document management, change assessments, registrations, regulatory intelligence, and inspection/audit readiness.

The ideal candidate brings hands-on experience in medical device or digital health regulatory affairs, strong operational discipline, and the ability to work cross-functionally with quality, engineering, product, clinical, and legal teams in a fast-paced environment.

• →Support regulatory operations for SaMD products across development, submission, launch, and post-market phases
• →Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence
• →Maintain regulatory documentation, including: submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, and change assessment logs
• →Partner with Regulatory Affairs leads to support FDA, EU, and other global market activities as applicable
• →Ensure submission content is complete, version-controlled, and aligned with internal document control requirements
• →Support design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modifications
• →Manage health authority document requests, submission calendars, and deadlines
• →Track and communicate submission milestones, approvals, renewals, and post-market reporting requirements
• →Support UDI, registration, listing, and market access maintenance activities where applicable
• →Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current and inspection-ready
• →Monitor evolving regulations, guidance, and standards relevant to SaMD, and help translate changes into operational actions
• →Collaborate with cross-functional stakeholders to improve regulatory processes, templates, and tools for scale and efficiency

• Bachelor’s degree in a scientific, engineering, healthcare, or related discipline
• 5+ years of experience in regulatory affairs or regulatory operations within medical devices, digital health, or other regulated healthcare products
• Experience supporting software-based medical products or SaMD
• Familiarity with key regulatory frameworks and standards, such as:
• FDA medical device requirements
• EU MDR
• ISO 13485
• IEC 62304
• ISO 14971
• Experience compiling and maintaining regulatory documentation in a controlled environment
• Strong project coordination, organization, and document management skills
• Excellent written and verbal communication skills
• Ability to manage multiple priorities and deadlines with strong attention to detail

• 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, and lifecycle documentation
• Understanding of cybersecurity, labeling, and post-market requirements for SaMD
• RAC certification or other relevant regulatory training is a plus
• Experience working in a fast-paced startup or high-growth medtech environment is preferred