Director - Post Market Quality

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 500,000 patients worldwide.

As the Director of Post-Market Quality , you own the systems that tell Heartflow how its products perform in the field, and the regulatory obligations that follow from what those systems reveal. You will lead the Designated Complaint Handling Unit, Product Investigations team, global adverse event reporting (FDA MDR, EU Vigilance), field actions, and the post-market surveillance processes required under EU MDR. This role requires deep, working expertise in post-market requirements applied to AI Software as a Medical Device (SaMD), where failure modes may be more algorithmic rather than mechanical. This role is highly visible with direct interaction and collaboration with leadership and executive management throughout Heartflow.

You will lead a high-performing team of complaint specialists, product investigators, and engineers working on investigations. You will lead the championing a Quality-first, patient-centric culture and driving data-driven decisions, while modernizing a proactive approach to obtaining feedback data as it relates to product quality and performance. Your ability to convert post-market signal into credible, timely input for risk management, CAPA, and design teams — under 21 CFR Parts 820, 803, and 806, EU MDR, ISO 13485, and ISO 14971 — is essential to our success.

Job Responsibilities :

Complaint Handling

• Working through the Manager of Complaint Handling, direct the designated complaint handling unit, ensuring intake, triage, documentation, investigation, and closure satisfy ISO 13485:2016, the FDA Quality Management System Regulation (21 CFR Part 820, as amended), and EU MDR requirements.

• Own complaint handling processes, procedures, and decision criteria, ensuring every complaint carries a robust documented reportability decision and a defensible closure rationale in the record.

• Approve closure of high-severity complaint files, including event coding to IMDRF adverse event terminology, and ensure coding is applied consistently enough to support credible and robust trending.

• Manage complaint cycle time against defined service levels, escalating aged, high-severity, or patient-impacting cases to the Executive Leadership Team.

• Ensure customer-facing investigation responses are technically accurate, consistent with the underlying investigation record, and insightful to the customers.

• Utilize emerging AI tools to incorporate improved quality, consistency, and efficiency within the complaint handling process and incorporate proactive monitoring of SaMD algorithm performance in the field.

Product Investigations

• Lead the Product Investigations (PI) function through the Manager of PI, ensuring root cause analysis is evidence-based, proportionate to risk, and traceable from the reported symptom through to disposition for robust trend analysis.

• Route confirmed product issues into CAPA, risk management file updates, and other non-conformance and corrective action subsystems.

• Enhance the investigation process to ensure a tiering system for product investigations, while partnering with R&D, Clinical, and Product Management on investigations requiring algorithm review and/or design enhancements.

Adverse Event Reporting

• Own reportability decision-making and timely submission of FDA Medical Device Reports under 21 CFR Part 803, including 30-day, 5-day, and supplemental reports.

• Own international reporting, including EU vigilance obligations under EU MDR and coordinate with the Heartflow Japan team to ensure proper and timely reporting to PMDA, including serious incident reporting and Field Safety Corrective Actions to Competent Authorities and the Notified Body within prescribed timelines.

• Maintain and defend the reportability decision trees, rationale documentation, and non-reportable justifications that underpin every complaint file.

• Govern reporting timeliness as a standing, executive-visible quality metric, with root cause and corrective action in case of any missed or late submission.

Field Actions, Recalls and Health Hazard Evaluation

• Own the Health Hazard Evaluation process in relation to the post-market processes.

• Ensure complaint files align with documented, risk-based assessment of severity, probability of occurrence, and population at risk.

• Direct corrections and removals under 21 CFR Part 806, including the written report to FDA within ten working days, engagement with the Recall Coordinator, and records for non-reportable actions.

EU MDR Post-Market Surveillance

• Own the Post-Market Surveillance (PMS) system under EU MDR including the PMS plan, the PMS Report, and the Periodic Safety Update Reports, as applicable to device classification.

• Direct Post-Market Clinical Follow-up planning and evaluation with Clinical and Regulatory Affairs, ensuring PMCF out

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