Senior Product and Regulatory Counsel

This is a fully remote position, open to applicants in Alaska, +8 more states.

📋 Description

• Act as the primary legal advisor on regulatory issues related to medical devices and digital health, collaborating with Regulatory Affairs and cross-functional teams to facilitate FDA submissions, global filings, and legal strategies for regulated product features.

• Offer strategic legal guidance throughout the entire product lifecycle, from initial ideation through to launch and subsequent market evolution.

• Proactively lead legal and regulatory strategies for complex initiatives that encompass wellness features, Software as a Medical Device (SaMD), AI-driven functionalities, and innovative health technologies.

• Provide counsel on healthcare compliance matters, including the Anti-Kickback Statute, product strategies, commercial models, research arrangements, and strategic partnerships.

• Create and enhance governance frameworks that incorporate regulatory, privacy, clinical, product, and commercial considerations.

• Advise on legal requirements for products, including claims, user-facing terms, disclosures, consent processes, and documentation for commercialization.

• Guide teams regarding AI-driven and algorithmic health features, focusing on validation, transparency, monitoring, and global regulatory compliance.

• Evaluate labeling, promotional materials, and marketing claims for compliance adherence.

• Counsel on post-market responsibilities, change control, product updates, and interactions with regulatory authorities.

• Prepare briefings for senior leadership on FDA, EU MDR, and other regulatory updates, translating these into actionable business guidance.

• Oversee external counsel, consultants, and internal stakeholders regarding specialized regulatory matters.

⛳️ Requirements

• Juris Doctor (J.D.) degree from an accredited law school in the United States.

• Active license to practice law in the U.S.

• Extensive relevant legal experience in advising on U.S. medical devices, healthcare, digital health, or regulated technology products; 10+ years preferred.

• In-depth knowledge of U.S. medical device regulatory frameworks, including general wellness products, SaMD, clinical evaluations, labeling, and post-market requirements.

• Proven experience in advising on or directly supporting FDA submissions for medical devices, SaMD, or related regulated features.

• Understanding of international medical device regulatory frameworks, such as EU MDR and applicable ISO standards.

• Capability to identify and mitigate risks in areas such as privacy, consumer protection, product governance, and marketing claims.

• Experience working within highly cross-functional product organizations and influencing product strategy.

• Excellent judgment and communication skills, adept at translating complex legal and regulatory requirements into practical guidance.

• Proven track record of independently managing complex matters and advising senior leadership.

• Preferred: experience with wearable technology, connected health products, or consumer health platforms.

• Preferred: familiarity with AI and machine-learning regulatory frameworks, including FDA guidelines and the EU AI Act.

• Preferred: prior experience in-house, in government, or within the medtech, digital health, or regulated consumer technology sectors.

• Preferred: experience advising on clinical studies or research activities involving regulated products.

🏝️ Benefits

• Competitive salary and equity offerings.

• Comprehensive health, dental, vision insurance, and mental health resources.

• An Oura Ring for your personal use along with employee discounts for friends and family.

• 20 days of paid time off, plus 13 paid holidays and 8 days of flexible wellness leave.

• Paid sick leave and parental leave.