# Director, Clinical Quality & Compliance 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
- Work setup: On-site
- Pay: $215K to $270K base salary per year (USD)
- Posted: 2026-09-15
- Apply by: 2026-10-30
- Apply: https://job-boards.greenhouse.io/heartflowinc/jobs/6194282004
- Page: https://www.1752.vc/careers/jobs/heartflow-director-clinical-quality-and-compliance/

## 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.

## What they're looking for

- Deep technical knowledge of FDA IDE regulations, FDA GCP standards, ISO 14155, and medical device labeling requirements
- Strong experience partnering closely with internal Clinical Operations teams to ensure robust GCP compliance in study management processes
- Direct hands-on experience hosting FDA BIMO audits and preparing sponsors/vendors for regulatory health authority inspections
- Demonstrated expertise reviewing and managing ICFs, IBs, IFUs, PMCF plans, and PSUR compilation
- Extensive background managing protocol deviations, CAPA systems, and UADE/SAE safety reporting within regulated clinical trials
- Understanding of multi-geographic clinical trial execution, data integrity, and cross-border regulatory considerations

Tags: Clinical