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HeartFlow is a publicly traded medical technology company (HTFL) that develops AI-driven diagnostic solutions for coronary artery disease, the leading cause of death worldwide. The company's flagship product, HeartFlow FFR_CT Analysis, uses cutting-edge AI to provide non-invasive cardiac assessment and is cleared for use across the US, UK, Europe, Japan, and Canada, with over 500,000 patient uses globally.
As Director of Post-Market Quality, you will own and lead all systems that monitor how HeartFlow products perform in the field and ensure compliance with complex regulatory obligations. This is a high-visibility leadership role reporting to executive management with direct responsibility for:
**Complaint Handling & Investigations**: Lead the Designated Complaint Handling Unit and Product Investigations team through direct reports (Manager of Complaint Handling and Manager of Product Investigations). You will oversee intake, triage, documentation, investigation, and closure of all complaints under ISO 13485:2016, FDA Quality Management System Regulation (21 CFR Part 820), and EU MDR requirements. You approve closure of high-severity complaints, ensure consistent event coding using IMDRF adverse event terminology, manage complaint cycle time against service levels, and escalate aged or patient-impacting cases to executive leadership. You will also enhance investigation processes with tiering systems and partner with R&D, Clinical, and Product Management on algorithm and design-related investigations.
**Adverse Event Reporting**: Own all reportability decision-making and timely submission of FDA Medical Device Reports (21 CFR Part 803), including 30-day, 5-day, and supplemental reports. Manage international reporting obligations under EU MDR vigilance and coordinate with the Japan team for PMDA reporting, serious incident reporting, and Field Safety Corrective Actions to Competent Authorities and Notified Bodies within prescribed timelines. Maintain and defend reportability decision trees and non-reportable justifications.
**Post-Market Surveillance**: Lead global adverse event reporting systems, field actions, and post-market surveillance processes required under EU MDR. This role requires deep expertise in post-market requirements for AI Software as a Medical Device (SaMD), where failure modes may be algorithmic rather than mechanical. You will drive a quality-first, patient-centric culture, convert post-market signals into credible input for risk management and CAPA teams, and modernize proactive feedback mechanisms for product quality and performance.
You will manage a high-performing team of complaint specialists, product investigators, and engineers. This role is essential to HeartFlow's regulatory compliance and product safety strategy, with visibility across the organization and direct collaboration with executive leadership.
