Director, Regulatory Affairs and Quality Assurance

Our mission at Oura is to make health a daily practice, empowering every person to own their  inner potential. Our award-winning products help our global community with daily insights to inspire healthy lifestyles. We've helped millions of people understand and improve their health. At Oura we are building a complete platform for preventative health, from sleep optimization to metabolic health, women’s health, stress management and heart health tracking. We view Oura Ring as a clinical grade device in a consumer package rather than as a technology product.  For us, empowering the world starts with living our values and empowering our team. As a quickly growing company we work to ensure that our team members have what they need to do their best work — both in and out of the office. We are looking for a Director, Regulatory Affairs and Quality Assurance to play a key role in shaping Oura’s future products and services. What you will do: Lead regulatory and quality strategy for product development, approval, and lifecycle management for all regulated features. Ensure compliance with FDA, CE (MDR), and other relevant global regulatory frameworks. Review marketing and promotional materials for regulated and general wellness features. Serve as the primary liaison with regulatory agencies and notified bodies. Guide the creation and submission of regulatory filings including 510(k)s, De Novo submissions, and international registrations. Partner with science, data science, engineering, clinical, marketing, and legal teams to integrate regulatory requirements into product design and development, including clinical evidence strategy. Oversee post-market surveillance, adverse event reporting, and regulatory audits. Build and manage the RA/QA team, including hiring, mentoring, and performance development. Monitor regulatory changes and trends, advising the executive team on potential business impacts. Ensure an effective Quality Management System (QMS). This is a remote US role. Requirements We would love to have you on our team if you have: Bachelor’s degree in life sciences, engineering, regulatory affairs, or a related field; advanced degree preferred. 8+ years of regulatory affairs experience in medical devices, digital health, or wearable technology, with experience in consumer-facing wearables strongly preferred. Proven track record of successful FDA submissions (510(k), De Novo) and international regulatory approvals. Proven track record of successful management of a quality system, including external audits. Deep understanding of software as a medical device (SaMD) and cybersecurity regulations. Experience with privacy and data regulations (e.g., HIPAA, GDPR). Excellent leadership, communication, and stakeholder management skills. Ability to thrive in a fast-paced, dynamic startup environment. Benefits At Oura, we care about you and your well-being. What we offer: Competitive salary and equity packages Health, dental, vision insurance, and mental health resources An Oura Ring of your own plus employee discounts for friends & family 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off Paid 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: $206,000 - $257,000 Region 2: $190,000 - $237,000 Region 3: $178,000 - $223,000  A recruiter can determine your zones/tiers based on your US location. We are not considering candidates residing in the following states: Alaska (AK), Arkansas (AR), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), Rhode Island (RI), South Dakota (SD), Vermont (VT), 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.