# Senior Regulatory Affairs Specialist at Function Health

- Company: Function Health
- What the company does: It’s time you own your health. Function includes 160+ lab tests and personalized protocols for instant action. Tracked over time in one secure place. Backed by Battery, General Catalyst and a16z.
- Company website: https://www.functionhealth.com/?utm_source=google&utm_medium=Google&utm_campaign=20800990020&utm_content={adid}&utm_term=function%20health&gad_source=1&gad_campaignid=20800990020&gbraid=0AAAAAqiw_KFExiKCoQ9G5NEKwcrrjePXb&gclid=Cj0KCQiAi9rJBhCYARIsALyPDttmpuDOephC5Um1LdEhfu26AqPmxZ67mRocG5lC6iFX7x2YcWSfeKMaArUgEALw_wcB
- Type: Startups
- Level: Senior
- Location: United States - Remote
- Work setup: Remote
- Posted: 2026-10-23
- Apply by: 2026-12-07
- Apply: https://jobs.gem.com/function-health/am9icG9zdDoEMoIjB3QCjklQfu62p057?utm_source=1752vc&utm_medium=careers
- Page: https://www.1752.vc/careers/jobs/function-health-senior-regulatory-affairs-specialist/

## About the role

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. Found on 1752vc Careers, the job board for startup and VC roles.

## What they're looking for

- 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)


Source: 1752vc Careers, https://www.1752.vc/careers/jobs/function-health-senior-regulatory-affairs-specialist/