Regulatory Specialist

Job Description

Heartflow is seeking a Regulatory Affairs Specialist to join its Quality and Regulatory Affairs team. This role is crucial in advancing the diagnosis and management of coronary artery disease through cutting-edge technology. The individual will support Heartflow's regulatory activities by collaborating with cross-functional teams on product changes and maintaining key regulatory documentation.Heartflow's flagship product, the AI-driven Heartflow FFRCT Analysis, provides a 3D model of a patient’s coronary arteries, aiding clinicians in identifying stenoses and assessing coronary blood flow.Responsibilities:

• Supporting frequent minor software releases through change assessments.
• Supporting the EU MDR application and maintenance of technical documentation.
• Collaborating with cross-functional teams to drive regulatory project management activities.
• Managing timely completion of new product registrations and maintaining global regulatory approvals.
• Collaborating with external partners, including regulatory agencies.
• Providing input to the risk management process.
• Conducting regulatory surveillance and communicating changes in regulations.
• Supporting Quality System management, as needed.

Requirements:

• Bachelor’s degree.
• 1-3 years of experience in Regulatory Affairs.
• Base knowledge of global regulatory requirements.
• Project management skills (a plus).
• Excellent communication, writing, and editing skills.
• Strong Word, Excel, and PowerPoint skills.
• Software medical device experience (a plus).

Heartflow offers:

• An estimated base salary.
• Cash bonus.
• Stock options.