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Senior Product and Regulatory Counsel

4 months, 2 weeks ago
United States
Full-time
Lead
Legal Counsel
Product Management
Agile Machine Learning
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 19

Description

  • Serve as the primary legal advisor on medical device regulatory requirements and support FDA submissions and global filings.
  • Partner with Product, Science, Regulatory Affairs, and Engineering teams from ideation through launch to align features with global standards and user experience.
  • Establish scalable governance frameworks that integrate regulatory, privacy, clinical, and product requirements across the product lifecycle.
  • Provide legal support for pre-market requirements, including review of user-facing terms, disclosures, and consent mechanisms.
  • Advise on AI-enabled and algorithm-driven health features, including transparency, validation, performance monitoring, and emerging machine learning regulations.
  • Support clinical validation strategy, including clinical study design and oversight, institutional review requirements, research partnerships, and real-world evidence use.
  • Review promotional materials, labeling, and marketing claims for compliance with consumer protection, advertising, and regulatory requirements.
  • Advise on post-market obligations, including change controls and interactions with regulatory authorities.
  • Support regulatory strategy for expansion into new international markets and jurisdictions.
  • Track and brief leadership on evolving FDA, EU MDR, and global developments affecting wearables and AI-enabled technology.

Requirements

  • Juris Doctor (J.D.) degree from an accredited U.S. law school.
  • Active license to practice law in the United States.
  • 8+ years of relevant legal experience.
  • Deep understanding of U.S. medical device regulations and FDA guidance for general wellness products, software as a medical device, clinical evaluation, labeling, and post-market obligations.
  • Demonstrated experience advising on or supporting FDA submissions for medical devices, SaMD, or related regulated features.
  • Familiarity with international medical device regulatory frameworks, including EU MDR and ISO standards.
  • Ability to identify and mitigate risks across data privacy, consumer protection, and marketing claims.
  • Demonstrated ability to work effectively in cross-functional product teams and influence strategy in highly iterative development environments.
  • Ability to translate complex legal requirements into practical advice for non-legal stakeholders.
  • Experience with wearable technology, connected health products, or consumer health platforms (preferred).
  • Familiarity with emerging AI and machine learning regulatory frameworks, including FDA guidance and the EU AI Act (preferred).
  • Prior in-house experience at the FDA or in a medtech, digital health, or regulated consumer technology company (preferred).
  • Experience advising on clinical studies and/or research activities involving regulated products (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.
  • Paid parental leave.
  • Remote US work arrangement with office and hybrid options in San Francisco, San Diego, and Los Angeles.

Interested in this position?

Apply directly on the company website

Apply Now

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