Enhance your health journey with Oura. The Oura Ring provides round-the-clock insights into sleep, fitness, and stress for wellness. Now HSA/FSA eligible. Backed by ICONIQ.
About the role
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.
What they're looking for
- 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
- ISO 13485
More about this role
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...
Browse similar: Startup jobs · Remote jobs