Overview
A leading consumer wellness technology company is seeking a Senior Product and Regulatory Counsel to serve as a senior individual contributor and strategic advisor. This role focuses on legal and regulatory strategy for consumer wellness and regulated digital health products, including Software as a Medical Device (SaMD). The position requires significant independence and influence across the organization, partnering closely with Product, Engineering, Science, Clinical, Regulatory Affairs, and executive teams.
Responsibilities
- Serve as primary legal advisor on medical device and digital health regulatory matters, supporting FDA submissions, global filings, and legal strategy for regulated product features.
- Provide strategic legal counsel throughout the product lifecycle, from ideation through launch and post-market activities.
- Lead legal and regulatory strategy for complex initiatives involving wellness features, SaMD, AI-enabled functionality, and emerging health technologies.
- Advise on healthcare compliance, including fraud and abuse laws such as the Anti-Kickback Statute, related to product strategy, commercial models, research, and partnerships.
- Develop and refine governance frameworks integrating regulatory, privacy, clinical, product, and commercial considerations.
- Counsel on product legal requirements including claims, user terms, disclosures, consent flows, and documentation for compliant commercialization across jurisdictions.
- Provide guidance on AI-enabled and algorithm-driven health features, including validation, transparency, monitoring, and evolving global regulations.
- Review labeling, promotional materials, and marketing claims for compliance with medical device, consumer protection, and advertising laws.
- Advise on post-market obligations, change control, product updates, and regulatory authority interactions.
- Prepare briefings for senior leadership on developments in FDA, EU MDR, and other global regulatory regimes affecting wearables, digital health, healthcare, and AI technologies.
- Manage external counsel, consultants, and internal stakeholders on specialized regulatory matters.
Requirements
- Juris Doctor (J.D.) degree from an accredited U.S. law school and active license to practice law in the United States.
- Significant legal experience (10+ years preferred) advising on U.S. medical device, healthcare, digital health, or other regulated technology products.
- Deep expertise in U.S. medical device regulatory frameworks, including general wellness products, SaMD, clinical evaluation, labeling, and post-market obligations.
- 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 relevant ISO standards.
- Strong risk identification and mitigation skills across privacy, consumer protection, product governance, and marketing claims.
- Proven ability to operate effectively within cross-functional product organizations and influence product strategy in fast-paced environments.
- Exceptional judgment and communication skills to translate complex legal and regulatory requirements into clear guidance.
- Track record of independently managing complex matters and serving as a trusted advisor to senior leaders.
Preferred Qualifications
- Experience with wearable technology, connected health products, or consumer health platforms.
- Familiarity with emerging regulatory frameworks for AI and machine learning in medical devices, including FDA guidance and the EU AI Act.
- Prior in-house, government, or medtech/digital health industry experience.
- Experience advising on clinical studies or research involving regulated products.
Compensation & Benefits
- Competitive salary and equity packages.
- Health, dental, vision insurance, and mental health resources.
- Company-provided wellness device plus employee discounts for friends and family.
- 20 days paid time off, 13 paid holidays, and 8 flexible wellness days.
- Paid sick leave and parental leave.
Salary ranges based on U.S. location tier:
- Region 1: $236,000 - $260,000
- Region 2: $212,000 - $232,000
- Region 3: $191,000 - $208,000
Note: Candidates residing in Alaska, Delaware, Iowa, Mississippi, Missouri, Nebraska, South Dakota, West Virginia, and Wisconsin will not be considered.
Location
This is a remote U.S. role with optional hybrid or office work available in San Francisco, San Diego, and Los Angeles. Employees in other major cities may gather at local co-working spaces.
Equal Opportunity
The organization is an equal opportunity employer committed to diversity and inclusion. Employment decisions are made without regard to age, ancestry, color, gender, gender identity or expression, genetic information, marital status, medical condition, disability, national origin, race, religion, sexual orientation, veteran status, or any other protected characteristic. Reasonable accommodations are provided for individuals with disabilities during the hiring process and employment.
Additional Information
Candidates should be cautious of fraudulent job offers. Official job postings are only available on the organization's careers page and trusted job boards. The employer does not request personal information or payment upfront and sends official offers through secure electronic signature platforms after verbal offers. Recruitment agencies are not accepted and unsolicited resumes will not be considered.