[Hiring] Senior Regulatory Affairs Specialist @Function Health

Role Description

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.
• 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.

Qualifications

• 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, including preparing submission content.
• Working knowledge of FDA device regulations and guidance, including general wellness, clinical decision support software, and AI-enabled device software, plus ISO 13485, ISO 14971, and IEC 62304.
• Familiarity with international medical device regulations, such as EU MDR and UK MHRA requirements.
• Working knowledge of quality management system requirements under ISO 13485 and 21 CFR Part 820 (QMSR).
• Experience reviewing labeling, marketing, and in-product claims.
• Clear writing, and the ability to turn regulatory requirements into practical guidance for product, engineering, and clinical teams.
• Comfortable using AI tools to speed up regulatory work, with the judgment to verify and correct their outputs.
• A bias toward action, and comfort prioritizing across several concurrent projects in a fast-moving environment.

Requirements

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

Benefits

• Competitive Base Salary
• Stock options
• Comprehensive health, dental, and vision plans for you and your family
• Flexible work environment
• Team off-sites and wellness initiatives
• Competitive vacation policy
• A culture that emphasizes continuous learning and personal growth

Company Description

Function 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.

• Recognized as one of Fast Company's Most Innovative Companies of 2024.
• Venture-backed by Redpoint and other leading venture firms.
• Over half a million members have joined Function to take control of their health.
• Building an integrated health platform that spans the full path from testing to health clarity to daily action.
• Recently announced a $298M Series B and is entering its next chapter of growth.