HeartFlow, Inc
HeartFlow, Inc. is a company pioneering in the field of cardiovascular diagnostics and care, utilizing advanced medical imaging and artificial intelligence. It offers a non-invasive personalized cardiac test that provides visualization of coronary arteries, allowing physicians to develop effective treatment plans for heart disease, which is the leading cause of death. HeartFlow’s technology combines human expertise and AI-powered tools to offer physicians critical insights without the need for invasive procedures, thus enhancing safety and efficiency in cardiovascular care. The company's solutions, such as the FFR CT Analysis, are widely adopted among top hospitals, delivering accurate and timely assessments of heart health.
Regulatory Specialist
March 6
HeartFlow, Inc
HeartFlow, Inc. is a company pioneering in the field of cardiovascular diagnostics and care, utilizing advanced medical imaging and artificial intelligence. It offers a non-invasive personalized cardiac test that provides visualization of coronary arteries, allowing physicians to develop effective treatment plans for heart disease, which is the leading cause of death. HeartFlow’s technology combines human expertise and AI-powered tools to offer physicians critical insights without the need for invasive procedures, thus enhancing safety and efficiency in cardiovascular care. The company's solutions, such as the FFR CT Analysis, are widely adopted among top hospitals, delivering accurate and timely assessments of heart health.
📋 Description
• Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease. • The Regulatory Affairs Specialist is part of the Quality and Regulatory Affairs team. • Support frequent minor software releases by performing change assessments. • Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices. • Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors. • Conduct regulatory surveillance and communicate changes in regulations, standards, and guidances. • Support Quality System management, as needed.
🎯 Requirements
• Bachelor’s degree • 1-3 years of experience in Regulatory Affairs • Software medical device experience a plus
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