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ŌURA
Senior Regulatory Affairs Specialist
Remote · USA · Senior level
$128k–$178k / year
About the role
Support regulatory strategy and operations for Software as a Medical Device portfolio. Drive compliant regulatory activities across product lifecycle.
What you’ll do
• Lead regulatory and quality strategy for product development and lifecycle. • Support regulatory operations for SaMD products. • Coordinate preparation and archival of regulatory submissions. • Maintain regulatory documentation and submission trackers. • Support design change assessments and regulatory filing impact.
What you’ll bring
• Bachelor’s degree in scientific, engineering, or healthcare discipline. • 5+ years in regulatory affairs or operations for medical devices or digital health. • Experience with software-based medical products or SaMD. • Familiarity with FDA, EU MDR, ISO 13485, IEC 62304, ISO 14971. • Work authorization for USA required.
Life at ŌURA
Competitive salary and equity packages. Health, dental, vision insurance and mental health resources. Oura Ring and employee discounts. Paid time off and parental leave.
About ŌURA
ŌURA empowers people to own their inner potential with products that provide insights on readiness, activity, and sleep quality.