Regulatory Specialist

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

• Support frequent mior 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, a cash bonus and stock options. HeartFlow is a mature start-up, pre-ipo market place leader, changing the paradigm in Coronary Artery Disease Diagnostics.