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Senior Regulatory Affairs Specialist

4 weeks ago
United States
Full-time
Senior
Compliance Manager
Operations
Cybersecurity
Apply Now
OURA

OURA

Oura Ring: The world's first wellness ring for accurate sleep and activity tracking, empowering users to make optimal daily choices for improved performance and well-being.

Health Care Providers & Services
251-1K
Founded 2013
$159M raised
View All Jobs 39

Description

  • Support regulatory operations for SaMD products across development, submission, launch, and post-market phases.
  • Coordinate the preparation, compilation, publishing, and archival of regulatory submissions and related correspondence.
  • Maintain regulatory documentation such as submission trackers, product registrations and 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 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 maintaining current documentation.
  • Monitor evolving regulations, guidance, and standards relevant to SaMD and 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 FDA medical device requirements, EU MDR, ISO 13485, IEC 62304, and 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.
  • Experience supporting 510(k), De Novo, technical documentation, or international registrations (preferred).
  • Familiarity with eQMS, document control, and submission management tools (preferred).
  • Experience with software change assessments, traceability, and lifecycle documentation (preferred).
  • Understanding of cybersecurity, labeling, and post-market requirements for SaMD (preferred).
  • RAC certification or other relevant regulatory training is a plus.
  • Experience working in a fast-paced startup or high-growth medtech environment is preferred.

Benefits

  • Competitive salary and equity packages.
  • Health, dental, and vision insurance.
  • Mental health resources.
  • An Oura Ring plus employee discounts for friends and family.
  • 20 days of paid time off, 13 paid holidays, and 8 days of flexible wellness time off.
  • Paid sick leave and parental leave.
  • A collaborative culture with passionate coworkers.

Interested in this position?

Apply directly on the company website

Apply Now

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