Senior Regulatory Affairs Specialist

US
- Remote Canada
- Remote

Medical Intelligence Lab

Remote

Full-time

Function Health is the AI operating system for health, designed to empower people to live 100 healthy years. We are redefining how individuals understand, measure, and improve their health by moving beyond the limitations of traditional care and enabling comprehensive, continuous insight into human biology. Function has been recognized as one of Fast Company's Most Innovative Companies of 2024, and is venture-backed by Redpoint and other leading venture firms.

Over half a million members have joined Function to take control of their health.

Through comprehensive lab testing, MRI and CT imaging, longitudinal data, and guidance from AI and clinical teams, Function gives members a complete and continuous view of their health, and the clarity to act on it. Through acquisitions across imaging, mobile phlebotomy, and supplement tracking and optimization, Function is building an integrated health platform that spans the full path from testing to health clarity to daily action.

Function recently announced a $298M Series B and is entering its next chapter of growth. As we scale, the quality and durability of our People systems, data, and insights will directly shape our ability to attract, retain, and support exceptional talent.

We are growing our team and seeking out world-class talent that deeply believes in our mission to positively impact global health, has a relentless bias toward action, and a growth mindset. Function fosters a collaborative and dynamic environment where every day we build the future.

As Function's products expand across lab testing, imaging, and AI-enabled software, regulatory judgment needs to arrive early and keep pace with how fast we build. As a Senior Regulatory Affairs Specialist, you will be a hands-on regulatory partner across our product and research teams: setting regulatory paths at the requirements stage, reviewing what our products say and do, supporting FDA and international submissions, and keeping regulatory records audit-ready.

If you are looking for a chance to shape how a fast-growing health platform approaches regulation from the inside, we'd love to hear from you. You will work across lab testing, imaging, and AI-enabled products in the same week, see your guidance turn into shipped features, and help build the regulatory foundation for products that reach hundreds of thousands of members.

If you like turning ambiguous regulatory questions into clear, defensible answers that help teams move faster, you will feel at home here.

This role reports to the Principal Regulatory Affairs Specialist / Director, Regulatory Affairs.

• Regulatory Pathways: Partner with product managers from the requirements stage to set the regulatory path for new features.
• Claims and Product Review: Review member-facing claims, user experience, and AI-generated outputs against general wellness, clinical decision support, and medical device boundaries.
• Launch Readiness: Prepare regulatory launch reviews and supporting documentation for sign-off.
• FDA Submissions: Author and coordinate sections of 510(k), De Novo, and Pre-Submission packages.
• Design Controls and Evidence: Support design control documentation, risk management, and verification and validation evidence planning.
• International Regulations: Support regulatory strategy, determinations, and submissions for international markets, such as the EU and UK.
• Quality System Support: Help maintain the quality management system elements that support regulatory work, including document control, design history files, CAPA input, and audit readiness.
• Change Management: Conduct regulatory change assessments for software, model, and labeling updates to cleared products.
• Regulatory Records: Maintain submission trackers, device determinations, change assessment logs, and agency correspondence.
• Regulatory Intelligence: Monitor FDA guidance and policy on digital health and AI-enabled devices, and translate it into clear direction for our teams.
• Scalable Processes: Build lightweight regulatory processes and templates that product and research teams can use on their own.

• 5+ years of regulatory affairs experience with medical devices, software as a medical device (SaMD), or diagnostics.
• Bachelor's degree in engineering, life sciences, or a related technical field.
• Hands-on experience with 510(k), De Novo, or Pre-Submission work,…