Senior 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 500,000 patients worldwide. The Opportunity As our Senior Complaint Specialist , you will play a critical role in ensuring the safety and regulatory integrity of our products after they reach clinicians and patients. You will be responsible for the end-to-end management of product complaints, ensuring that every report is handled with the highest level of technical accuracy and regulatory compliance. This role is a key pillar of our post-market surveillance strategy, bridging the gap between customer feedback and continuous quality improvement.

Requirements

Regulatory Knowledge and deep understanding of 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDR, Health Canada MPR, ISO13485, and ISO 14971
Proficient with Salesforce, Tableau, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office
Strong critical thinking skills and great attention to detail
Ability to work as a self-starter in a fast-paced, adaptive environment and mentor team members
Excellent communication, documentation, and time management skill
Ability to stay current with global regulatory requirements and industry best practices
Bachelor’s degree in Science, Engineering, or a related field.
5+ years of relevant experience in the medical device industry, software medical device products (class II/III) preferred.

Responsibilities

Assess reports received through multiple customer feedback channels to identify alleged deficiencies, ensure accurate documentation, and manage timely complaint review and closure.
Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to external regulatory authorities as required to ensure compliance with global regulatory requirements, including but not limited to FDA (21 CFR 820, 803, 806) and EU MDR.
Collect, evaluate, and analyze complaints data to identify trends, potential risks, and opportunities for product improvement.
Provide support on the maintenance of department documents and procedures; participate in Quality Management System (QMS) activities and Risk Management activities, including Health Hazard Evaluations (HHE), CAPA, and Nonconformance Reports (NCR).
Provide support on product field action activities, including identification, risk assessment, stakeholder communication, and coordination of corrective actions.
Assist Customer Support and serve as a technical liaison for complaint escalations, providing support on complaint closure approvals; Provide guidance and mentorship to team members on process execution and regulatory requirements.
Identify efficiencies in our surveillance workflows to scale our operations