Director, Clinical Quality & Compliance

🏢 Heartflowinc · 📍 San Francisco, California 💰 $215,000 - $240,000 / yr

⚡ Direct Talent Broker Referral

Why apply through CandidatesReach?

✔ Tailored Executive Endorsement Letter: Highlight your real strengths and verified background directly to hiring leads.

✔ Your Preferred Screening Terms: Choose between a 1-minute quick phone screen or scheduled email calendar.

✔ $500 Cash Hiring Bonus: Receive $500 direct cash reward after 30 days of active employment.

Position Summary & Responsibilities

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_CTAnalysis—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_CTAnalysis), 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 Quality & Compliance is responsible for the strategic oversight, management, and execution of clinical quality assurance and regulatory compliance programs across pre-market and post-market clinical research initiatives. The Director will work closely with internal Clinical Operations teams and cross-functional partners to support and monitor compliance, ensure adherence with FDA IDE requirements and Good Clinical Practice (GCP), and maintain inspection readiness across all studies, both internally managed and externally initiated or managed.

Job Responsibilities:

Leads clinical quality and regulatory compliance strategies and initiatives across

🎯 Candidate Preparation Guide For Heartflowinc Applicants

Key Role Competencies & Evaluation Highlights

Key Role Focus:

The medical technology panel strictly evaluates clinical precision, regulatory (FDA) clearance awareness, and the ability to translate advanced computational fluid dynamics into cardiology insights.

📋 Preparation Priorities (Key Areas to Clarify):

1. Minimizes the strict regulatory validation steps required for software-as-a-medical-device (SaMD)
2. Shows casual regard for data accuracy in life-critical diagnostic software
3. Lacks the technical depth to discuss numerical simulation or clinical workflow integration

✨ Recommended Role Alignment Hook:

I scale life-saving medical software by pairing rigorous regulatory compliance with cutting-edge computational cardiovascular insights.

🔒 Free Candidate Preparation Access

Unlock Preparation Priorities & Alignment Hook

🤝 Talent Broker Referral · $500 Bonus Included

Apply for Director, Clinical Quality & Compliance

Setup your contact terms & referral note to get recommended directly to the hiring lead at Heartflowinc.

⚡ Continue with Google (Instant Setup)

or with email

Already have an account? Sign in here