Senior Product and Regulatory Counsel
Ō
ŌuraConsumer Wellness Technology, Digital Health
Remote - United StatesFull-TimeSenior
Salary117300 - 169000 USD per year
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Job Details
- Experience
- 8+ years
Requirements
- Juris Doctor (J.D.) degree from an accredited U.S. law school
- Active license to practice law in the United States with 8+ years of relevant legal experience
- Deep understanding of U.S. medical device regulations and guidance, including applicable FDA frameworks for general wellness products, software as a medical device, clinical evaluation, labeling, and post-market obligations
- Demonstrated experience advising on and/or directly 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 diverse regulatory domains, including data privacy, consumer protection, and marketing claims
- Demonstrated ability to operate effectively within cross-functional product teams and influence product strategy in highly iterative development environments
- Collaborative mindset with an exceptional ability to translate complex legal requirements into actionable, practical advice for non-legal stakeholders in a fast-paced environment
- Experience working with wearable technology, connected health products, or consumer health platforms (preferred)
- Familiarity with emerging regulatory frameworks governing AI and machine learning in medical devices, 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)
Responsibilities
- Serve as the primary legal advisor on medical device regulatory requirements, partnering with Regulatory Affairs to support Oura’s FDA submissions and global filings and helping shape the legal and regulatory strategy for regulated product features.
- Partner cross-functionally with Product, Science, Regulatory Affairs, and Engineering teams from the ideation stage to ensure features are built to meet global standards without sacrificing user experience.
- Establish scalable product development governance frameworks that integrate regulatory, privacy, clinical, and product requirements throughout the product lifecycle.
- Provide comprehensive legal support for pre-market requirements, including the review of user-facing terms, disclosures, and consent mechanisms to ensure global alignment.
- Advise on legal and regulatory considerations for AI-enabled and algorithm-driven health features, including issues related to model transparency, validation, performance monitoring, and emerging regulatory frameworks governing machine learning.
- Provide legal guidance on clinical validation strategies, including the design and oversight of clinical studies, institutional review requirements, research partnerships, and the use of real-world evidence to support regulatory submissions.
- Review promotional materials, labeling, and marketing claims for compliance with applicable consumer protection laws, advertising standards, and regulatory requirements.
- Provide legal input on post-market requirements, including change controls and interactions with regulatory authorities.
- Support regulatory strategy for entry into new international markets and jurisdictions. Track and brief leadership on evolving FDA, EU MDR, and global regulatory developments on the regulation of wearables and AI-enabled technology to future-proof Oura’s long-term product roadmap.
- Coordinate with external counsel and specialized consultants on complex regulatory filings or specialized product legal matters as needed.
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