Senior Regulatory Affairs Specialist

Heartflow is a medical technology company that advances the diagnosis and management of coronary artery disease. We're seeking a Senior Regulatory Affairs Specialist to coordinate and support regulatory activities for our products.

Requirements

• Familiarity with current regulatory thinking around software and AI medical device software development
• Direct experience with generating modular submission documentation and working with various regulatory agencies
• Strong problem-solving skills and ability to work independently and collaboratively
• Leadership and interpersonal skills to develop and manage good working relationships
• Excellent communication and stakeholder management skills
• Strong project management skills with ability to coordinate cross-functional teams

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off
• Tuition Reimbursement
• Healthcare Services