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

Health Care

251-1K (600)

Founded 2013

$159M raised

21 open positions

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Senior Product and Regulatory Counsel

3 months, 3 weeks ago

United States

Full-time

Lead

Legal Counsel

Product Management

Agile Machine Learning

Apply Now

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 21

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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