Regulatory Specialist

Summary

Join Heartflow, a leading medical technology company revolutionizing precision heart care, as a Regulatory Affairs Specialist. You will be part of the Quality and Regulatory Affairs team, contributing to the company's global regulatory activities. This role involves supporting software releases, managing regulatory documentation, collaborating with cross-functional teams and external partners, and ensuring compliance with global regulations. The ideal candidate possesses 1-3 years of experience in Regulatory Affairs, a bachelor's degree, and excellent communication and project management skills. Heartflow offers a competitive salary, cash bonus, and stock options in a fast-paced, supportive environment.

Requirements

• Base knowledge of global regulatory requirements
• Bachelor’s degree
• 1-3 years of experience in Regulatory Affairs
• Excellent communication, writing, and editing skills
• Strong Word, Excel, and PowerPoint skills

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

Preferred Qualifications

• Project management skills
• Demonstrated team collaboration
• Software medical device experience

Benefits

• Estimated base salary of $90,000 - $105,000
• Cash bonus
• Stock options