Senior Product and Regulatory Counsel

Overview

A growing company specializing in consumer wellness technology and regulated digital health products is seeking a Senior Product and Regulatory Counsel. This role involves serving as a lead strategic advisor at the intersection of wearable technologies and regulated digital health, guiding cross-functional teams through the development, validation, and commercialization of a portfolio that includes general wellness and regulated Software as a Medical Device (SaMD) features.

Responsibilities

• Act as the primary legal advisor on medical device regulatory requirements, collaborating with Regulatory Affairs to support FDA submissions and global filings.
• Shape legal and regulatory strategy for regulated product features.
• Partner with Product, Science, Regulatory Affairs, and Engineering teams from ideation through product development to ensure compliance with global standards while maintaining user experience.
• Establish scalable governance frameworks integrating regulatory, privacy, clinical, and product requirements throughout the product lifecycle.
• 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, performance monitoring, and emerging regulatory frameworks.
• Guide clinical validation strategies, including design and oversight of clinical studies, institutional review requirements, research partnerships, and use of real-world evidence for regulatory submissions.
• Review promotional materials, labeling, and marketing claims for compliance with consumer protection laws, advertising standards, 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 related to wearables and AI-enabled technology.
• Coordinate with external counsel and specialized consultants on complex regulatory filings or specialized legal matters as needed.

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 and guidance, 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, 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 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 in a fast-paced environment.

Preferred Qualifications

• Experience with wearable technology, connected health products, or consumer health platforms.
• Familiarity with emerging regulatory frameworks governing 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 and research activities involving regulated products.

Compensation & Benefits

• Competitive salary and equity packages.
• Health, dental, and vision insurance, plus mental health resources.
• Company-provided wearable device and 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 are market-based and vary by U.S. location tier:

• Region 1: $165,000 - $220,000
• Region 2: $155,000 - $198,000
• Region 3: $145,000 - $177,000

Salary offers depend on 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 informally at local co-working spaces.

Candidates residing in Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), South Dakota (SD), West Virginia (WV), and Wisconsin (WI) will not be 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 (including pregnancy or related conditions), gender identity or expression, genetic information, marital status, medical condition, mental or physical disability, national origin, protected family care 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 to participate in the interview process and perform essential job functions.

Additional Information

Candidates should be cautious of fraudulent job offers. Official job listings appear only on trusted job boards and the organization's careers page. Personal information or payment for equipment is never requested upfront. Official offers are sent through secure electronic signature platforms after verbal offers.

Recruitment agencies should note that unsolicited resumes are not accepted and the organization is not responsible for fees related to unsolicited submissions.