Senior Regulatory Affairs Specialist
Ōura · Other
Source: Oura
This role’s source listing does not include Hungary as an eligible location.
Ōura is seeking a Senior Regulatory Affairs Specialist to manage regulatory operations for Software as a Medical Device products, with the role being fully remote within the United States.
The specialist will drive regulatory strategy and documentation for the company's SaMD portfolio, ensuring compliance across product lifecycles. Key responsibilities include supporting submissions, managing registrations, performing change assessments, and maintaining audit readiness in collaboration with cross-functional teams.
Why You’ll Love This Role
What You’ll Bring
What You’ll Get
About the Company
Ōura is a health-technology company that produces the Oura Ring, a wearable device focused on sleep and activity tracking. They aim to empower individuals to improve their health through data-driven daily insights.