Senior Complaint Specialist
HeartFlow
This listing was originally posted on HeartFlow's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moHeartflow 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 FFRCT 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 (FFRCT 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.
Job Description:
The Senior Complaint Specialist requires experience in the medical device industry with a clear understanding of medical device complaint handling processes, trending, and regulatory reporting procedures. This role will be responsible for identifying, reviewing, and processing complaints for evaluation as required by applicable regulations, standards, and company procedures. This role serves as a primary subject matter expert for complaint escalations and ensures that all reporting requirements to domestic and international regulatory authorities are completed accurately and on time.
Job Responsibilities:
Skills Needed:
Educational Requirements & Work Experience:
This position has an estimated base salary of $75,000 to $100,000 and bonus. #LI-IB1; #LI-Hybrid
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