Support regulatory operations for SaMD products across development, submission, launch, and post-market phases
Coordinate preparation, compilation, publishing, and archival of regulatory submissions and related correspondence
Maintain regulatory documentation, including: submission trackers, product registrations/listings, regulatory commitments, approvals and clearance records, and change assessment logs

Requirements:

5+ years of experience in regulatory affairs or regulatory operations within medical devices, digital health, or other regulated healthcare products
Experience supporting software-based medical products or SaMD
Familiarity with key regulatory frameworks and standards, such as: FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, ISO 14971

Preferred Qualifications:

Experience supporting 510(k), De Novo, technical documentation, or international registrations
Familiarity with eQMS, document control, and submission management tools
Experience with software change assessments, traceability, and lifecycle documentation

Oura

Oura's mission is to empower every person to own their inner potential. Their award-winning products help their global community gain a deeper knowledge of their readiness, activity, and sleep quality by using their Oura Ring and its connected app. As a quickly growing company focused on helping people live healthier and happier lives, they ensure that their team members have what they need to do their best work — both in and out of the office.

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