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Salary: USD 61,000 - 75,000 / annual
HeartFlow is a publicly traded medical technology company (HTFL) that develops AI-driven diagnostic solutions for coronary artery disease, the leading cause of death worldwide. The flagship product, HeartFlow FFR_CT Analysis, provides a non-invasive cardiac test that generates 3D models of coronary arteries to assess blood flow impact. The company has received international recognition, is cleared for use in the US, UK, Europe, Japan, and Canada, and has been used for over 750,000 patients globally.
As a Complaint Specialist, you will be a core part of HeartFlow's post-market surveillance system, protecting patient safety and regulatory integrity. You will manage product complaints from intake through closure, ensuring every report is evaluated, documented, and assessed for reportability accurately and on time. Working closely with Senior Complaint Specialists, Customer Support, and cross-functional partners, you will drive continuous quality improvement through customer feedback.
Key Responsibilities:
- Assess reports from multiple customer feedback channels to identify alleged deficiencies, ensure accurate documentation, and manage timely complaint review and closure
- Perform and document regulatory reporting determinations; prepare Medical Device Reports (MDRs) and vigilance reports for FDA, EU, UK, and other global regulatory authorities
- Review complaint investigations for completeness, root cause rationale, and documentation quality; escalate potential safety signals when appropriate
- Assist with complaint data requests to support trending and management review
- Support Quality Management System activities including CAPA, Nonconformance Reports (NCR), Health Hazard Evaluations (HHE), risk management, and audits
- Partner with Customer Support as a liaison for complaint escalations, clarifying event details and gathering additional information
- Help maintain complaint handling tools and procedures; identify workflow optimization opportunities as the business scales
Requirements:
- Bachelor's degree
- 0–2 years of relevant experience in the medical device industry, preferably in complaint handling or post-market surveillance
- Experience with software medical devices (Class II/III) preferred
- Working knowledge of US and international post-market requirements: FDA Quality Management System Regulation (21 CFR 820, incorporating ISO 13485), 21 CFR 803, 21 CFR 806, EU MDR, UK MDR 2002, Health Canada Medical Devices Regulations, and Japan PMD Act
- Knowledge of ISO 14971 (risk management for medical devices)
- Strong critical thinking skills and attention to detail
- Excellent communication, documentation, and time management skills
- Ability to work independently in a fast-paced, adaptive environment and collaborate well within a team
- Experience with Salesforce, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office
The role is hybrid, requiring four days per week in the Austin, TX office.
