Senior Post-Market Surveillance Specialist
Heartflow(20 days ago)
About this role
The Senior Post-Market Surveillance Specialist at Heartflow will ensure product safety and regulatory compliance after product release by developing and maintaining post-market surveillance frameworks. The role connects real-world safety data with engineering and cross-functional teams to drive continuous product improvement and global compliance.
Required Skills
- Post-Market
- Regulatory Reporting
- Data Analysis
- Trend Analysis
- Risk Management
- CAPA
- Field Actions
- Complaint Handling
- Salesforce
- Tableau
+2 more
Qualifications
- Bachelor's Degree in Science or Engineering
- 8+ Years Medical Device Experience
About Heartflow
heartflow.comHeartFlow, 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.
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