# Principal Regulatory Affairs Specialist at HeartFlow

- Company: HeartFlow
- What the company does: Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.
- Company website: https://www.heartflow.com
- Type: Startups
- Level: Principal and up
- Location: San Francisco, California; Rohnert Park, California
- Work setup: On-site
- Pay: $188K to $240K base salary per year (USD)
- Posted: 2026-09-30
- Apply by: 2026-11-23
- Apply: https://job-boards.greenhouse.io/heartflowinc/jobs/6211315004?utm_source=1752vc&utm_medium=careers
- Page: https://www.1752.vc/careers/jobs/heartflow-principal-regulatory-affairs-specialist/

## About the role

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFR CT Analysis—provides a color-coded, 3D model of a patient’s coronary arteries indicating the impact blockages have on blood flow to the heart. Found on 1752vc Careers, the job board for startup and VC roles.

## What they're looking for

- Bachelor’s Degree in Computer Science (ML/AI), Biomedical Engineering, Software Engineering, Electrical Engineering, or a related scientific field
- Direct experience successfully clearing or approving SaMD applications (e.g., 510(k), De Novo, or CE Mark) with FDA and/or EU Notified Bodies
- Able to clearly work towards established goals and initiatives with minimal oversight
- Strong ability to translate complex software engineering language into clear regulatory rationale for health authorities
- Excellent communication skills (written, verbal, editing)
- Proven track record working effectively within software development environments

Tags: Regulatory Affairs

Source: 1752vc Careers, https://www.1752.vc/careers/jobs/heartflow-principal-regulatory-affairs-specialist/