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Oura is seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy and operations for its Software as a Medical Device (SaMD) portfolio. The role spans the full product lifecycle—from development and submission through launch and post-market phases—supporting compliance and efficient execution across wellness and regulated features.
Key responsibilities include leading regulatory and quality strategy for product development and lifecycle management; coordinating preparation and archival of regulatory submissions and correspondence; maintaining comprehensive regulatory documentation (submission trackers, product registrations, approvals, change assessments); supporting design change assessments to determine filing impact for software updates and product modifications; tracking submission milestones, approvals, and post-market reporting requirements; supporting UDI, registration, and market access activities; contributing to inspection and audit readiness by organizing regulatory evidence; monitoring evolving regulations and standards relevant to SaMD; and collaborating cross-functionally with quality, engineering, product, clinical, and legal teams to improve regulatory processes and tools for scale.
The ideal candidate brings 5+ years of hands-on regulatory affairs or operations experience in medical devices, digital health, or regulated healthcare products, with specific expertise in software-based medical products or SaMD. Required qualifications include a bachelor's degree in a scientific, engineering, healthcare, or related discipline; familiarity with FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971; experience compiling and maintaining regulatory documentation in controlled environments; strong project coordination and document management skills; and excellent written and verbal communication abilities. Preferred qualifications include experience with 510(k), De Novo, or international registrations; familiarity with eQMS and submission management tools; software change assessment and traceability expertise; understanding of cybersecurity and post-market SaMD requirements; RAC certification; and experience in fast-paced startup or high-growth medtech environments.
