Senior Regulatory Affairs Specialist
Benefits
6w PTO
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Role Overview:
- Seeking a Senior Regulatory Affairs Specialist for SaMD portfolio.
- Drive compliance and efficiency across product lifecycle.
Responsibilities:
- Lead regulatory strategy and coordinate submissions.
- Maintain documentation and support change assessments.
- Monitor regulations and collaborate cross-functionally.
Requirements:
- 5+ years in regulatory affairs, experience with SaMD and FDA/EU MDR.
- Strong project coordination and documentation skills.
Oura
Oura empowers people to own their inner potential through its award-winning Oura Ring and connected app, providing daily insights on readiness, activity, and sleep. As a quickly growing health technology company, Oura fosters a culture of empowerment and well-being, ensuring team members have the resources to do their best work.