Senior Regulatory Affairs Specialist

Heartflow(13 days ago)

San Francisco, California, Rohnert Park, CaliforniaOnsiteFull TimeSenior$110,000 - $145,000Regulatory Affairs

About this role

Heartflow is a medical technology company that develops AI-driven, non-invasive cardiac diagnostic tools to improve coronary artery disease diagnosis and management. The Senior Regulatory Affairs Specialist is an individual contributor who coordinates and supports global regulatory activities across product development, market entry, and post-market surveillance to ensure regulatory compliance for Heartflow products.

View Original Listing

Required Skills

Regulatory Strategy
Submission Management
SaMD
AI Regulation
Compliance
Project Management
Stakeholder Management
Communication
Quality Assurance
Documentation

Qualifications

Bachelor's Degree in Science, Engineering or Related Field

About Heartflow

heartflow.com

HeartFlow, headquartered in Redwood City, California, is a health technology company that provides non-invasive coronary artery disease assessment by applying AI and computational fluid dynamics to coronary CT angiography to create patient-specific 3D models. Its flagship HeartFlow Analysis (FDA-cleared and CE-marked) quantifies blood flow and identifies flow-limiting blockages to help clinicians decide if a patient needs invasive angiography or revascularization. Deployed in hospitals and health systems globally, the platform aims to improve diagnostic accuracy, reduce unnecessary invasive procedures, shorten time to diagnosis, and lower overall costs.