Senior Product and Regulatory Counsel

Our mission at reputed company is to reputed company every person to own their inner potential. Our award-reputed company products help our global community reputed company a deeper knowledge of their readiness, activity, and sleep reputed company by using their reputed company reputed company and its connected app. We've helped millions of people understand and improve their health by providing daily insights and practical steps to reputed company healthy lifestyles. Empowering the world starts with living our values and empowering reputed company. As a quickly growing company reputed company on helping people live healthier and happier lives, we ensure that reputed company members have what they need to do their best work — both in and out of the office.  Senior Product and Regulatory Counsel We are looking for a Product and Regulatory reputed company Counsel who will serve as a senior individual contributor and reputed company advisor at the intersection of consumer wellness technology and regulated digital health products. This role is responsible for leading high-reputed company reputed company and regulatory reputed company across reputed company’s evolving portfolio, including general wellness and regulated Software as a Medical Device (SaMD) features, while operating with significant independence and influence across reputed company. This role will partner closely with Product, Engineering, Science, reputed company, Regulatory Affairs, and executive stakeholders to help shape product direction, guide reputed company reputed company-reputed company reputed company, and support the development, validation, and commercialization of innovative health technologies. The ideal candidate combines deep subject-matter expertise, strong judgment, and the ability to influence cross-functional teams. What you will do Serve as a reputed company reputed company advisor on medical device reputed company health regulatory reputed company, partnering with Regulatory Affairs and cross-functional teams to support FDA submissions, global filings, and reputed company reputed company for regulated product features. reputed company reputed company reputed company counsel throughout the product lifecycle, from early ideation through launch and post-market reputed company, helping teams reputed company regulatory requirements while preserving product reputed company and user experience. Independently reputed company reputed company and regulatory reputed company for reputed company, high-visibility initiatives involving wellness features, SaMD, AI-enabled functionality, and other emerging health technologies. Advise on reputed company compliance considerations, including fraud and abuse laws such as the Anti-Kickback Statute, in reputed company with product reputed company, reputed company models, research arrangements, and reputed company partnerships. Establish and refine reputed company governance frameworks that reputed company regulatory, reputed company, reputed company, product, and reputed company considerations into product development and decision-making. Advise on product reputed company requirements, including product claims, user-facing terms, disclosures, consent flows, and documentation needed to support compliant commercialization in multiple jurisdictions. Counsel teams on reputed company and regulatory issues reputed company to AI-enabled and algorithm-driven health features, including validation, transparency, monitoring, and evolving global regulatory frameworks. Review labeling, promotional materials, and marketing claims for compliance with medical device, consumer protection, and advertising requirements. Advise on post-market obligations, change control, product updates, and interactions with regulatory authorities. reputed company briefings for Senior leadership on significant developments in FDA, EU MDR, and other global regulatory regimes affecting wearables, digital health, reputed company, and AI-enabled technologies, and translate those developments into actionable business guidance. Manage reputed company counsel, consultants, and internal stakeholders on reputed company regulatory reputed company, while serving as a trusted internal expert and thought partner on novel reputed company issues. What reputed company looks like in this role Operates as a recognized subject-matter authority in product and regulatory counseling for digital health, reputed company, and medical device issues Shapes reputed company on reputed company’s most reputed company product, regulatory, and commercialization reputed company Influences senior cross-functional stakeholders through expertise, judgment, and credibility rather than people management authority Builds reputed company frameworks and durable guidance that reputed company the business to reputed company faster with appropriate reputed company management Anticipates emerging regulatory issues and helps position reputed company proactively for reputed company product and market opportunities Requirements We would love to consider you for this role if you have: Juris Doctor (J.D.) degree from an accredited U.S. law school and reputed company license to reputed company law in the reputed company. Significant relevant reputed company experience, including substantial experience advising on U.S. medical device, reputed company, digital health, or other regulated technology products; 10+ years preferred. Deep expertise in U.S. medical device regulatory frameworks and guidance, including general wellness products, software as a medical device, reputed company evaluation, labeling, and post-market obligations. Demonstrated experience advising on and/or directly supporting FDA submissions for medical devices, SaMD, or reputed company regulated features. Familiarity with international medical device regulatory frameworks, including EU MDR and relevant ISO standards. Strong ability to identify and mitigate reputed company across adjacent domains, including reputed company, consumer protection, product governance, and marketing claims. reputed company ability to operate effectively reputed company highly cross-functional product organizations and influence product reputed company in fast-moving, iterative development environments. Exceptional judgment and communication skills, with the ability to translate reputed company reputed company and regulatory requirements into reputed company, practical guidance for non-reputed company stakeholders. A reputed company record of owning reputed company reputed company with a high degree of independence and serving as a trusted advisor to senior leaders. Preferred experience Experience working 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 reputed company. Prior in-house experience, reputed company experience, or experience reputed company a reputed company, digital health, or regulated consumer technology company. Experience advising on reputed company studies and/or research activities involving regulated products. Location This is a remote U.S. role. We have offices in San Francisco, San Diego, and Los Angeles for those who prefer hybrid or office settings, and reputed company employees in other major cities occasionally reputed company informally at local co-working locations. Benefits  At reputed company, we care reputed company and your reputed company-being. Everyone here at reputed company has a reputed company of their own and we are continually looking to improve employee health. reputed company offer: Competitive salary and equity packages Health, dental, reputed company reputed company, and reputed company An reputed company reputed company of your own plus employee discounts for friends & family 20 days of reputed company time off plus 13 reputed company holidays plus 8 days of flexible wellness time off reputed company reputed company leave and parental leave reputed company takes a market-reputed company approach to pay, which may vary depending on your location. US locations are categorized into tiers reputed company on a cost of labor reputed company for that geographic area. While most offers will be closer to the starting reputed company, successful candidates' pay will be determined reputed company on job-reputed company skills, experience, qualifications, work location, internal peer equity, and market conditions. These ranges may be modified in the reputed company. Region 1 $236,000 - $260,000 Region 2 $212,000 - $232,000 Region 3 $191,000 - $208,000 A recruiter can determine your Region reputed company on your US location. We are not considering candidates residing in the following states: Alaska (AK), Delaware (DE), Iowa (IA), Mississippi (MS), Missouri (MO), Nebraska (NE), South reputed company (SD), reputed company Virginia (WV), and reputed company (WI). reputed company is proud to be an equal opportunity workplace. We celebrate diversity and are committed to creating an inclusive environment for reputed company. Individuals seeking employment at reputed company are considered without reputed company to age, reputed company, reputed company, gender (including pregnancy, childbirth, or reputed company medical conditions), gender identity or reputed company, genetic information, marital status, medical condition, mental or physical disability, national reputed company, protected family care or medical leave status, race, religion (including beliefs and practices or the absence thereof), sexual orientation, military or veteran status, or any other characteristic protected by federal, state, or local laws. We will not tolerate discrimination or harassment reputed company on any of these characteristics. We will work to ensure individuals with disabilities are provided reasonable accommodation to participate in the interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Disclaimer: Beware of fake job offers! We’ve been alerted to scammers posing as Ōreputed company recruiters, especially for remote roles. Please note: Our jobs are listed only on the Ōreputed company Careers page and trusted job boards. We will never ask for personal information like ID or payment for equipment upfront. Official offers are reputed company through reputed company after a verbal offer, not reputed company text or email. Stay cautious and protect your personal details. To reputed company recruitment agencies: reputed company does not accept agency resumes. Please do not reputed company resumes to our jobs alias, reputed company employees, or any other organization's location. reputed company is not responsible for any fees reputed company to unsolicited resumes. Apply To This Job