Regulatory Affairs Specialist at Function Health

, , United States -

Full Time

Start Date

Immediate

Expiry Date

18 Feb, 26

Salary

0.0

Posted On

20 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Medical Devices, SaMD, Quality Standards, Global Submissions, AI/ML, Risk Management, Cross-Functional Collaboration, Detail-Oriented, Fast-Paced Environment

Industry

technology;Information and Internet

Description

Company Overview: About Function & Ezra Function Health was founded with a singular focus: empower you to live 100 healthy years. We’re doing that by using the best available technology to ensure people don’t suffer or die a preventable death. Function has been recognized as one of Fast Company’s Most Innovative Companies of 2024 and is venture-backed by Andreessen Horowitz (a16z). Hundreds of thousands of members have joined Function to take control of their health. In 2025, Function acquired Ezra, the leading provider of MRI screening for early cancer detection. Ezra pioneered accessible, AI-enhanced MRI imaging to help people catch cancer and other diseases at their earliest, most treatable stages. By bringing Ezra into Function’s ecosystem, we’re combining world-class screening with advanced lab testing and cutting-edge technology — creating the most comprehensive preventive health platform on the market. Our Mission at Ezra Our mission at Ezra is to detect cancer early for everyone in the world. We offer a direct-to-consumer cancer screening service that leverages MRI and Artificial Intelligence to make cancer screening fast, accurate, and affordable. We are fully operational in multiple states such as New York, California, and Florida with an MRI-based screening program covering 13 organs. We believe in empowering people to be proactive with their health decisions. Our members sign up for an Ezra, visit a partner imaging center to get an MRI scan, and receive a comprehensive screening report within 7-10 days. Role: As a Regulatory Affairs Specialist at Ezra, you will: Execute post-market surveillance activities and maintain ongoing compliance for our SaMD products across multiple jurisdictions Support regulatory submissions by preparing, compiling, and coordinating applications for FDA, CE Mark, and other global medical device approvals Conduct regulatory assessments for new products, product enhancements, and changes to existing devices Review and provide regulatory input on labeling, instructions for use, and technical documentation Maintain global product registrations, facility listings, and establishment registrations Contribute to the development of regulatory strategy and stay current on evolving SaMD regulations Liaise with regulatory bodies and respond to regulatory inquiries Provide input on Quality Risk Management activities Assist in post-market compliance activities including CAPA investigations, complaint handling, and internal audits Provide input on Quality Risk Management, Product Design and Development Risk Management activities Help ensure procedures enable operations and engineering teams to work eﬃciently within regulatory requirements Assist with external audits and regulatory inspections as needed Key Responsibilities: Requirements: 3+ years of hands-on regulatory affairs experience with medical devices, preferably including SaMD 3+ years working with quality standards: 21 CFR Part 820, ISO 13485:2016, and MDSAP Global product submissions experience ML experience for submissions. Familiarity with AI/ML-enabled medical devices and their unique regulatory considerations Proven experience in regulated software development environments (medical device, pharma, aviation, or nuclear) Experience developing regulatory strategies specifically for SaMD products Strong understanding of risk-based decision making and quality risk management principles Excellent cross-functional collaboration and communication skills Detail-oriented with the ability to manage multiple priorities in a fast-paced startup environment Nice to haves: RAPS Regulatory Affairs Certification (RAC) or ASQ Certified Quality Auditor (CQA) 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: 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

Responsibilities

The Regulatory Affairs Specialist will execute post-market surveillance activities and maintain ongoing compliance for SaMD products. They will support regulatory submissions and conduct assessments for new products and enhancements.