Senior Regulatory Affairs Specialist

Our mission at ŌURA is to empower every person to own their inner potential. Our award-winning products help our global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to inspire healthy lifestyles. Empowering the world starts with living our values and empowering our team. As a quickly growing company focused on helping people live healthier and happier lives, we ensure that our team members have what they need to do their best work — both in and out of the office. We are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy/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. What You Will Do • Lead regulatory and quality strategy for product development, approval, and lifecycle management for wellness and regulated features. • Support regulatory operations lead 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 • change assessment logs • Support design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modifications • 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 Requirements: • 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 Preferred Qualifications: • 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,