Regulatory Affairs Specialist - Remote

Overview

The Regulatory Affairs Specialist is part of the Quality and Regulatory Affairs team at Heartflow, a medical technology company focused on advancing the diagnosis and management of coronary artery disease through innovative technology.

In Short

• Support frequent minor software releases by performing change assessments.
• Assist with EU MDR application and maintenance of technical documentation.
• Collaborate with cross-functional teams on regulatory project management activities.
• Manage new product registrations and maintain global regulatory approvals.
• Work with external partners including regulatory agencies and distributors.
• Gain experience with US FDA submissions.
• Provide input to the risk management process during the product life-cycle.
• Conduct regulatory surveillance and communicate changes in regulations.
• Support Quality System management as needed.
• Ability to work in a fast-paced adaptive environment.

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 skills in Word, Excel, and PowerPoint.

Benefits

• Competitive salary range.
• Cash bonus and stock options.
• Work in a supportive and inspiring environment.
• Equal Opportunity Employer.