We are redirecting you to the source. If you are not redirected in 3 seconds, please click here.

Director, Regulatory Affairs and Quality Assurance at Oura. 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.. 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.. . Company Location: United States.