Overview
A growing company in the consumer wellness technology and digital health space is seeking a Senior Product and Regulatory Counsel. This role involves providing strategic legal guidance at the intersection of consumer wellness products and regulated digital health offerings, including Software as a Medical Device (SaMD). The position requires navigating complex global regulatory frameworks such as FDA and EU MDR, collaborating closely with Product, Engineering, Clinical, and Regulatory Affairs teams to support product development, validation, and commercialization.
Responsibilities
- Serve as the primary legal advisor on medical device regulatory requirements, supporting FDA submissions and global filings.
- Shape legal and regulatory strategies for regulated product features.
- Collaborate cross-functionally from ideation through product lifecycle to ensure compliance with global standards while maintaining user experience.
- Establish scalable governance frameworks integrating regulatory, privacy, clinical, and product requirements.
- Provide legal support for pre-market requirements, including review of user-facing terms, disclosures, and consent mechanisms.
- Advise on legal and regulatory considerations for AI-enabled and algorithm-driven health features, including model transparency, validation, and performance monitoring.
- Guide clinical validation strategies, including clinical study design, institutional review, research partnerships, and use of real-world evidence.
- Review promotional materials, labeling, and marketing claims for compliance with consumer protection laws and regulatory requirements.
- Provide legal input on post-market requirements such as change controls and regulatory authority interactions.
- Support regulatory strategy for entry into new international markets and track evolving FDA, EU MDR, and global regulatory developments.
- Coordinate with external counsel and specialized consultants on complex regulatory filings or legal matters.
Requirements
- Juris Doctor (J.D.) degree from an accredited U.S. law school.
- Active license to practice law in the United States.
- Minimum of 8 years of relevant legal experience.
- Deep understanding of U.S. medical device regulations, including FDA frameworks for general wellness products, SaMD, clinical evaluation, labeling, and post-market obligations.
- Demonstrated experience advising on or supporting FDA submissions for medical devices or related regulated features.
- Familiarity with international medical device regulatory frameworks including EU MDR and ISO standards.
- Ability to identify and mitigate risks across regulatory domains such as data privacy, consumer protection, and marketing claims.
- Proven ability to operate effectively within cross-functional product teams and influence product strategy in iterative development environments.
- Strong collaborative skills with the ability to translate complex legal requirements into practical advice for non-legal stakeholders.
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 experience at the FDA or in medtech, digital health, or regulated consumer technology companies.
- Experience advising on clinical studies or research activities involving regulated products.
Compensation & Benefits
- Competitive salary and equity packages.
- Health, dental, and vision insurance.
- Mental health resources.
- Company-provided wearable device 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.
Salary ranges based on U.S. location tiers:
- Region 1: $143,650 - $169,000
- Region 2: $130,050 - $153,000
- Region 3: $117,300 - $138,000
Compensation is determined by skills, experience, qualifications, work location, internal equity, and market conditions.
Location
This is a remote U.S. role. Offices are available in San Francisco, San Diego, and Los Angeles for those preferring hybrid or office settings. Employees in other major U.S. cities occasionally gather at local co-working spaces.
Candidates residing in Alaska, Delaware, Iowa, Mississippi, Missouri, Nebraska, South Dakota, West Virginia, and Wisconsin are not being considered.
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, family or medical leave status, race, religion, sexual orientation, military or veteran status, or any other protected characteristic.
Reasonable accommodations are provided for individuals with disabilities during the interview process and employment.
Additional Information
Candidates should be cautious of fraudulent job offers. Official job postings are only available on trusted job boards. The employer will not request personal information or payment for equipment upfront. Official offers are sent through secure electronic signature platforms after verbal offers.
Recruitment agencies are not accepted; unsolicited resumes will not be considered or compensated.