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Oura
Senior Regulatory Affairs Specialist
legalfull-timeRemote - United States
SALARY
Not listed
WORK TYPE
hybrid
JOB TYPE
full-time
INDUSTRY
healthcare
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About the role
About Oura
Oura empowers every person to own their inner potential. Award-winning products help the global community gain deeper knowledge of their readiness, activity, and sleep quality using the Oura Ring and connected app.
Role Overview
We are seeking a Senior Regulatory Affairs Specialist to support regulatory 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.
Key Responsibilities
- Submission support
- Document management
- Change assessments
- Registrations
- Regulatory intelligence
- Inspection and audit readiness
Location
US based role with strong preference for the East Coast. Hybrid work available with offices in San Francisco, San Diego, and Los Angeles for those who prefer in-office settings.
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