Senior Regulatory Affairs Specialist
ŌURA
full-time
Posted on:
Location Type: Remote
Location: Alaska • Iowa • United States
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Salary
💰 $151,300 - $178,000 per year
Job Level
About the role
- 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
- Partner with Regulatory Affairs leads to support FDA, EU, and other global market activities as applicable
- Ensure submission content is complete, version-controlled, and aligned with internal document control requirements
- Support design change assessments and help determine regulatory filing impact for software updates, labeling changes, and product modifications
- Manage health authority document requests, submission calendars, and deadlines
- Track and communicate submission milestones, approvals, renewals, and post-market reporting requirements
- Support UDI, registration, listing, and market access maintenance activities where applicable
- Contribute to inspection and audit readiness by organizing regulatory evidence and ensuring documentation is current and inspection-ready
- Monitor evolving regulations, guidance, and standards relevant to SaMD, and help translate changes into operational actions
- Collaborate with cross-functional stakeholders to improve regulatory processes, templates, and tools for scale and efficiency
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, 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
- Experience compiling and maintaining regulatory documentation in a controlled environment
- Strong project coordination, organization, and document management skills
- Excellent written and verbal communication skills
- Ability to manage multiple priorities and deadlines with strong attention to detail
Benefits
- Competitive salary and equity packages
- Health, dental, vision insurance, and mental health resources
- An Oura Ring of your own plus employee discounts for friends & family
- 20 days of paid time off plus 13 paid holidays plus 8 days of flexible wellness time off
- Paid sick leave and parental leave
- Amazing culture of collaborative and passionate coworkers
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory operationsregulatory submissionsregulatory documentationsubmission trackersproduct registrationschange assessmentUDIISO 13485IEC 62304ISO 14971
Soft Skills
project coordinationorganizationdocument managementwritten communicationverbal communicationattention to detailability to manage prioritiescollaborationefficiency improvement