The Opportunity

As our Complaint Specialist, you will help protect the safety of patients and the regulatory integrity of the Heartflow platform after it reaches clinicians. You will manage product complaints from intake through closure, making sure every report is evaluated, documented, and assessed for reportability accurately and on time. This role is a core part of our post-market surveillance system and connects customer feedback to continuous quality improvement.

Job Description:

The Complaint Specialist identifies, reviews, and processes complaints as required by applicable regulations, standards, and company procedures. Working closely with Senior Complaint Specialists, Customer Support, and cross-functional partners, you will make sure investigations are complete and well documented and that regulatory reporting decisions are properly justified.

Job Responsibilities:

• Complaint Handling: Assess reports received through multiple customer feedback channels to identify alleged deficiencies, ensure accurate documentation, and manage timely complaint review and closure.
• Regulatory Assessment: Perform and document regulatory reporting determinations. Prepare Medical Device Reports (MDRs) and vigilance reports for review and submission to FDA, EU, UK, and other global regulatory authorities as required.
• Investigation Review: Review complaint investigations for completeness, root cause rationale, and quality of documentation. Escalate potential safety signals when appropriate.
• Trending & Metrics Support: Assist with complaint data requests as needed to support trending and management review.
• Quality System Support: Support Quality Management System activities, including CAPA, Nonconformance Reports (NCR), Health Hazard Evaluations (HHE), risk management, and internal and external audits.
• Cross-Functional Liaison: Partner with Customer Support and serve as a liaison for complaint escalations, including clarifying event details and gathering additional information.
• Process Optimization: Help maintain complaint handling tools and procedures and find ways to streamline workflows as the business scales.

Skills Needed:

• Working knowledge of US and international post-market requirements, including 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 great attention to detail
• Excellent communication, documentation, and time management skills
• Ability to work independently in a fast-paced, adaptive environment and to collaborate well within a team.
• Experience with Salesforce, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office

Educational Requirements & Work Experience:

• Education: Bachelor’s degree
• Experience: 0-2 years of relevant experience in the medical device industry, preferably in complaint handling or post-market surveillance Experience with software medical (Class II/III) preferred.

This position follows a hybrid schedule requiring the employee to work from: Austin, TX Office: Four times per week

This position has an estimated base salary of $61,000 to $75,000 and bonus. #LI-IB1; #LI-Hybrid