Director Clinical Quality and Compliance

The role

The Director of Clinical Quality & Compliance provides strategic oversight and management of clinical quality assurance and regulatory compliance programs. This role supports pre-market and post-market clinical research initiatives through close partnership with Clinical Operations and cross-functional teams.

What you will do

• Leads clinical quality and regulatory compliance strategies across pre-market and post-market programs.
• Ensures clinical trial compliance with FDA GCP guidelines and ISO 14155.
• Oversees medical device labeling requirements for post-market and investigational devices.
• Authors, reviews, and maintains Investigator’s Brochures.
• Leads BIMO audit preparation, internal GCP audits, vendor oversight, and regulatory inspections.
• Works with Clinical Operations and CRO teams to align study protocols and trial management with regulatory standards.
• Establishes clinical trial monitoring protocols and oversees deliverables like ICFs and TMF quality standards.
• Partners with Clinical Operations to review regulatory document packages for site greenlighting.
• Manages regulatory compliance oversight for UADE and SAE reporting workflows.
• Implements oversight for logging and mitigating protocol deviations and non-compliance via RCA and CAPA.

Required qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Clinical Research, or related scientific/health field
• Minimum of 8 years relevant experience in clinical quality assurance and regulatory affairs within medical device, biotech, or combination product industries
• Experience managing CROs and clinical vendors
• Deep technical knowledge of FDA IDE regulations, FDA GCP standards, ISO 14155, and medical device labeling requirements
• 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
• Understanding of multi-geographic clinical trial execution, data integrity, and cross-border regulatory considerations
• Strong matrix leadership and collaboration skills
• Incredible attention to detail, accuracy, and quality
• Ability to manage multiple tasks and work in an environment with shifting priorities
• Excellent written and oral English communication skills

Nice to have

• Master's, Ph.D., PharmD, or RN
• Demonstrated experience leading BIMO audit readiness and FDA IDE submissions

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven technology. It is a publicly traded company that provides an integrated heart care solution across the CCTA pathway.