Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.
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
More about this 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. Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFR CT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 750,000 patients worldwide.
The Director, Clinical...
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