Senior Regulatory Affairs Specialist

Oura
United States
Workplace: RemoteFull timeFunction: Quality & Regulatory (Non-Software)Experience: 5+ yearsEducation: bachelorsSkills: ["Operational discipline","Project coordination","Document management","Cross-functional collaboration","Attention to detail"]

Own regulatory strategy and operations for a Software as a Medical Device (SaMD) portfolio across the product lifecycle. Lead planning and execution of submissions support, document management, change assessments, registrations/listings, and post-market reporting. Maintain controlled regulatory records, monitor evolving FDA/EU MDR standards and guidance, and ensure audit/inspection readiness by organizing regulatory evidence and translating updates into operational actions with cross-functional teams.

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FursaFursa
Oura
Oura
1 day ago

Senior Regulatory Affairs Specialist

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Source: Company careers pageValidated by: Fursa AI
Last checked: 11 hours agoStatus: Live
Reposted: similar role first listed 3 months ago

Job Summary

Own regulatory strategy and operations for a Software as a Medical Device (SaMD) portfolio across the product lifecycle. Lead planning and execution of submissions support, document management, change assessments, registrations/listings, and post-market reporting. Maintain controlled regulatory records, monitor evolving FDA/EU MDR standards and guidance, and ensure audit/inspection readiness by organizing regulatory evidence and translating updates into operational actions with cross-functional teams.
Location: United States
Workplace: Remote
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Lead regulatory and quality strategy for wellness and regulated features across development, approval, and lifecycle management.
  • •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, registrations/listings, regulatory commitments, approvals/clearance records, and change assessment logs.
  • •Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current.

Pay and Benefits

Equity and Bonus:Equity
Perks:Health InsuranceDentalVisionEquityPaid LeavePaid SickParental Leave

Key Requirements

  • •Bachelor’s degree in a scientific, engineering, healthcare, or related discipline.
  • •5+ years of experience in regulatory affairs or regulatory operations within medical devices or digital health (or other regulated healthcare products).
  • •Experience supporting software-based medical products or SaMD.
  • •Familiarity with regulatory frameworks and standards including FDA requirements, EU MDR, ISO 13485, IEC 62304, and ISO 14971.
  • •Experience compiling and maintaining regulatory documentation in a controlled environment.
Experience:5+ yearsMedical devicesDigital healthSaMDRegulated healthcareMedtech
Education:Bachelor's
Skills:Operational disciplineProject coordinationDocument managementCross-functional collaborationAttention to detail
Certifications:RAC
Languages:English
Tech Stack:FDAEU MDRISO 13485IEC 62304ISO 14971UDI510(k)De NovoEQMS

Company Brief

Oura
Designs and sells the Oura Ring, a wearable device that tracks sleep, activity, and physiological signals to provide personalized health, recovery, and readiness insights via a companion app and analytics platform.
Industry: Wearables
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Funding: Series C
Headquarters: Oulu, Finland
Founded: 2013
WebsiteLinkedIn