Senior Regulatory Affairs Specialist

Company Overview

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.

Role

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.

Key Responsibilities

• 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.

Qualifications & Skills

• 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.

Preferred Background

• AI/ML-enabled device experience, including predetermined change control plans and performance evaluation.
• Laboratory-developed tests, CLIA, or in vitro diagnostics.
• Imaging devices.
• Device cybersecurity and post-market obligations, including complaint handling and adverse event reporting.
• IRB submissions and oversight of human subjects research.
• MDSAP audit experience.
• RAC certification and experience at a startup or consumer health company.

To be a strong fit, you embody our Core Values

Ruthless Prioritization:

• We don't let perfect get in the way of progress.
• We move quickly to drive value, not perfection.
• We prioritize what drives impact.
• We never compromise on standards of excellence.

Member-First, Always:

• We design and deliver like we're caring for someone we love.
• We create clear, actionable, human experiences.
• We prioritize responsiveness, peace of mind, and outcomes.
• We empower members with truth, clarity, and care.

One Team, Moving Fast:

• We are aligned in purpose, prioritization, and speed.
• We gather diverse perspectives to make informed decisions.
• We clear paths for each other and move fast together.
• We communicate clearly and respectfully, rallying around shared goals.

Radical Ownership, Relentless Execution:

• We don't just ship; we own outcomes and drive results.
• We act with urgency and precision.
• We anticipate, initiate, and follow through.
• We meet challenges with grit and pragmatism.
• We embrace new tech to deliver better outcomes.

Mission Over Ego:

• We are ruthlessly aligned to our mission, and leave ego at the door.
• We disagree and commit.
• We don't tolerate politics or withholding information.
• We operate with honesty, transparency, and respect.

Sustained Integrity in Every Detail:

• We earn trust by obsessing over accuracy, quality, and clarity in everything we do.
• We prioritize clinical precision; data must be right.
• We sweat the details because outcomes depend on them.

Why You'll Love Working With Us

As a Senior Regulatory Specialist you'll have the opportunity to make meaningful contributions within a fast-growing company helping people live 100 healthy years. You'll also have access to:

• 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

We value our team at Function and offer a competitive salary and benefits package, flexible working hours, and a dynamic work environment where creativity and innovation are encouraged. If you are a highly motivated and experienced individual who is passionate about using technology to improve people's lives, we would love to hear from you.

At Function, we celebrate diversity and are committed to building a diverse and inclusive workforce. As an equal opportunity employer, we do not discriminate on the basis of race, color, gender identity, ancestry, religion, age, sexual orientation, national origin, disability, marital status, Veteran status, or any other occupationally irrelevant criteria.

Join the Function Health team and become a part of our mission to build a healthier future for all. Discover more about us and how we're changing the face of healthcare at Function Health.

Important Notice: Legitimate communication from the Function Health team will always come from an email address ending in @functionhealth.com. Function Health will never request personal information such as banking details or payment during the hiring process. Please be cautious of communications or job offers that come from other email domains, instant messaging platforms, or unsolicited calls. If you ever have doubts about the legitimacy of a communication, please reach out to us directly at [email protected].