Senior Regulatory Affairs Specialist

ŌURA · Remote, USA

Full-timeRemoteToday

Not open to applicants in Nigeria. This employer hires from: United States only. Apply only if you are based there.

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About this role

This remote role at ŌURA supports regulatory strategy and operations for the company's Software as a Medical Device portfolio, covering submissions, registrations, change assessments, documentation, and inspection readiness across the product lifecycle. The ideal candidate has hands-on experience in medical device or digital health regulatory affairs, strong operational discipline, and the ability to coordinate with quality, engineering, product, clinical, and legal teams in a fast-paced setting. A standout requirement is the ability to lead regulatory and quality strategy for both wellness and regulated product features.

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