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 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 VC-backed company 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 400,000 patients worldwide.
The Regulatory Affairs Specialist is part of the Quality and Regulatory Affairs team. The individual has 1-3 years of experience in Regulatory with an understanding of regulatory requirements and is able to resolve a wide-range of issues while maintaining compliance to regulations and standards. This individual will play a key role in HeartFlow regulatory activities involving cross-functional collaboration for product changes, as well as maintenance of key regulatory documentation. #LI-Remote; #LI-IB1
Job Responsibilities:- Support frequent minor software releases by performing change assessments
- Support EU MDR application and maintenance of technical documentation, including clinical evaluation
- Collaborate with cross-functional teams to drive regulatory project management activities
- 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
- Gain experience with US FDA submissions
- Provide input to the risk management process to ensure risks are identified and updated during the product life-cycle
- Conduct regulatory surveillance and communicate changes in regulations., standards, and guidances
- Support Quality System management, as needed
- Other relevant duties as assigned
- Ability to work in a fast-paced adaptive environment, self-starter, and strong team player
- Base knowledge of global regulatory requirements
- Project management skills a plus
- Demonstrated team collaboration
- Excellent communication, writing, and editing skills
- Strong Word, Excel, and PowerPoint skills
- Bachelor’s degree
- 1-3 years of experience in Regulatory Affairs
- Software medical device experience a plus
This position has an estimated base salary of $90,000 - $105,000 and cash bonus.
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