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Senior Regulatory Labeling Specialist at Heartflow - ApplyBlast

Senior Regulatory Labeling Specialist

Heartflow

20 days ago

3.0 on Glassdoor

San Francisco, California, United States

Onsite

Full Time

Senior

0 applicants

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About this role

Heartflow is seeking a Senior Regulatory Labeling Specialist to ensure compliance across core regulatory functions, focusing on authoring and maintaining Instructions for Use (IFU) and other labeling. The role involves conducting regulatory reviews of promotional and marketing materials, leveraging IT systems to streamline documentation, and supporting global product lifecycle management. This position bridges technical writing, regulatory compliance, and cross-functional collaboration to support precision heartcare innovations.

Responsibilities

Author and maintain Instructions for Use and technical labeling
Review marketing and promotional materials for regulatory compliance
Manage electronic document management systems and regulatory databases

Skills

About Heartflow

heartflow.com

Headquarters

San Francisco, California, United States

Company Size

201-500 employees

Founded

2010

View Profile

Heartflow, headquartered in San Francisco, California, is a health technology company focused on transforming coronary artery disease (CAD) diagnosis and long-term management. Its AI-powered Heartflow One platform converts coronary CT angiography (CCTA) scans into detailed, patient-specific 3D models of the heart, offering tools including FFRCT Analysis for blood flow assessment, Roadmap Analysis for CAD detection, Plaque Analysis for disease quantification and risk stratification, and a PCI Navigator for intervention planning. Deployed across more than 1,800 institutions globally, Heartflow aims to improve diagnostic accuracy, personalize treatment pathways, and reduce unnecessary invasive procedures.