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Salary: USD 215,000 - 270,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) advancing the diagnosis and management of coronary artery disease using AI-driven cardiac imaging. The company's flagship product, HeartFlow FFR_CT Analysis, is a non-invasive AI-driven test that provides 3D models of coronary arteries to help clinicians assess blood flow impact and identify stenoses. The product is cleared for use in the US, UK, Europe, Japan, and Canada, and has been used for over 750,000 patients worldwide.
The Director, Clinical Quality & Compliance will lead strategic oversight and execution of clinical quality assurance and regulatory compliance programs across pre-market and post-market clinical research initiatives. This role manages compliance with FDA IDE requirements and Good Clinical Practice (GCP) standards, maintains inspection readiness, and works closely with internal Clinical Operations teams and cross-functional partners.
Key responsibilities include:
- Leading clinical quality and regulatory compliance strategies across pre-market and post-market internal and external clinical programs
- Ensuring robust end-to-end clinical trial compliance with FDA GCP guidelines (21 CFR Parts 50, 56, 312, 812) and ISO 14155
- Overseeing medical device labeling requirements and compliance with FDA regulations and international standards
- Authoring, reviewing, and maintaining Investigator's Brochures (IB) for investigational medical devices
- Leading Bioresearch Monitoring (BIMO) audit preparation, internal GCP audits, vendor oversight, and external regulatory inspections
- Collaborating with Clinical Operations and external CRO teams to ensure study protocols align with regulatory and quality standards
- Establishing clinical trial monitoring protocols and overseeing key deliverables including Informed Consent Forms (ICFs), site monitoring plans, and Trial Master File (TMF) quality standards
- Managing regulatory compliance for Unanticipated Adverse Device Effects (UADE) and Serious Adverse Event (SAE) reporting, ensuring FDA 10-day reporting compliance
- Implementing systematic oversight for protocol deviations and non-compliance, including root-cause analysis (RCA) and Corrective and Preventive Actions (CAPA)
- Establishing quality oversight and compliance metrics for field monitors and study personnel
- Partnering with Regulatory Affairs on post-market obligations including Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) studies, and Periodic Safety Update Reports (PSUR)
- Contributing to FDA IDE regulatory strategies and submissions
- Navigating geographic data governance, data privacy, and cross-border clinical regulatory requirements for multi-site global trials
- Participating in process improvement activities within the department and cross-functionally
Requirements:
- Minimum Bachelor's degree in Life Sciences, Biomedical Engineering, Clinical Research, or related scientific/health field (Master's, Ph.D., PharmD, or RN preferred)
- Minimum 8 years relevant experience in clinical quality assurance and regulatory affairs within the medical device, biotech, or combination product industries
- Deep technical knowledge of FDA IDE regulations, FDA GCP standards, ISO 14155, and medical device labeling requirements
- Strong experience partnering with internal Clinical Operations teams to ensure robust GCP compliance
- Direct hands-on experience hosting FDA BIMO audits and preparing sponsors/vendors for regulatory 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
- Experience managing CROs and clinical vendors (required)
- Strong matrix leadership and collaboration skills with ability to drive cross-functional compliance
- Excellent 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
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and Google tools
- Demonstrated experience leading BIMO audit readiness and FDA IDE submissions (preferred)
- Proven track record of working in close alignment with internal Clinical Operations teams
