Complaint Specialist

Heartflow•Austin, TX

1d•Hybrid

About The Position

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 750,000 patients worldwide. The Opportunity As our Complaint Specialist , you will help protect the safety of patients and the regulatory integrity of the Heartflow platform after it reaches clinicians. You will manage product complaints from intake through closure, making sure every report is evaluated, documented, and assessed for reportability accurately and on time. This role is a core part of our post-market surveillance system and connects customer feedback to continuous quality improvement.

Requirements

Working knowledge of US and international post-market requirements, including FDA Quality Management System Regulation (21 CFR 820, incorporating ISO 13485), 21 CFR 803, 21 CFR 806, EU MDR, UK MDR 2002, Health Canada Medical Devices Regulations, and Japan PMD Act
Knowledge of ISO 14971 (risk management for medical devices)
Strong critical thinking skills and great attention to detail
Excellent communication, documentation, and time management skills
Ability to work independently in a fast-paced, adaptive environment and to collaborate well within a team.
Experience with Salesforce, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office
Bachelor’s degree
0-2 years of relevant experience in the medical device industry, preferably in complaint handling or post-market surveillance

Nice To Haves

Experience with software medical (Class II/III) preferred.

Responsibilities

Complaint Handling: Assess reports received through multiple customer feedback channels to identify alleged deficiencies, ensure accurate documentation, and manage timely complaint review and closure.
Regulatory Assessment: Perform and document regulatory reporting determinations. Prepare Medical Device Reports (MDRs) and vigilance reports for review and submission to FDA, EU, UK, and other global regulatory authorities as required.
Investigation Review: Review complaint investigations for completeness, root cause rationale, and quality of documentation. Escalate potential safety signals when appropriate.
Trending & Metrics Support: Assist with complaint data requests as needed to support trending and management review.
Quality System Support: Support Quality Management System activities, including CAPA, Nonconformance Reports (NCR), Health Hazard Evaluations (HHE), risk management, and internal and external audits.
Cross-Functional Liaison: Partner with Customer Support and serve as a liaison for complaint escalations, including clarifying event details and gathering additional information.
Process Optimization: Help maintain complaint handling tools and procedures and find ways to streamline workflows as the business scales.