Senior Regulatory Affairs Specialist

Our mission at Oura 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 phasesCoordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondenceMaintain regulatory documentation, including:submission trackersproduct registrations/listingsregulatory commitmentsapprovals and clearance recordschange assessment logsSupport design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modificationsTrack and communicate submission milestones, approvals, renewals, and post-market reporting requirementsSupport UDI, registration, listing, and market access maintenance activities where applicableContribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current and inspection-readyMonitor evolving regulations, guidance, and standards relevant to SaMD, and help translate changes into operational actionsCollaborate 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 discipline5+ years of experience in regulatory affairs or regulatory operations within medical devices, digital health, or other regulated healthcare productsExperience supporting software-based medical products or SaMDFamiliarity with key regulatory frameworks and standards, such as:FDA medical device requirementsEU MDRISO 13485IEC 62304ISO 14971Experience compiling and maintaining regulatory documentation in a controlled environmentStrong project coordination, organization, and document management skillsExcellent written and verbal communication skillsAbility to manage multiple priorities and deadlines with strong attention to detail Preferred Qualifications Experience supporting 510(k), De Novo, technical documentation, or international registrationsFamiliarity with eQMS, document control, and submission management toolsExperience with software change assessments, traceability, and lifecycle documentationUnderstanding of cybersecurity, labeling, and post-market requirements for SaMDRAC certification or other relevant regulatory training is a plusExperience working in a fast-paced startup or high-growth medtech environment is preferred Benefits At Oura, we care about you and your well-being. Everyone here at Oura has a ring of their own and we are continually looking to improve employee health. What We Offer Competitive salary and equity packagesHealth, dental, vision insurance, and mental health resourcesAn Oura Ring of your own plus employee discounts for friends & family20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time offPaid sick leave and parental leave Oura takes a market-based approach to pay, which may vary depending on your location. US locations are categorized into tiers based on a cost of labor index for that geographic area. While most offers will be closer to the starting range, successful candidates' pay will be determined based on job-related skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the future. Region 1: $151,300 - $178,000 Region 2: $138,550 - 163,000Region 3: $127,500 - $150,000 A recruiter can determine your zones/tiers based on your US location. We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Nebraska (NE), South Dakota (SD), West Virginia (WV), and Wisconsin (WI). Oura is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for all employees. Individuals seeking employment at Oura are considered without regard to age, ancestry, color, gender (including pregnancy, childbirth, or related medical conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment based on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as ŌURA recruiters, especially for remote roles. Please note: Our jobs are listed only on the ŌURA Careers page and trusted job boards.We will never ask for personal information like ID or payment for equipment upfront.Official offers are sent through Docusign after a verbal offer, not via text or email. Stay cautious and protect your personal details. To all recruitment agencies: Oura does not accept agency resumes. Please do not forward resumes to our jobs alias, Oura employees, or any other organization's location. Oura is not responsible for any fees related to unsolicited resumes.