← All roles

Complaint Specialist

Heartflow· Quality
Apply on company site
Hybrid (Austin, TX)$61k - $75kPosted 3w ago

About the role

Role focused on post-market surveillance to protect patient safety and regulatory integrity of the Heartflow platform by managing product complaints from intake to closure and ensuring accurate regulatory reporting and documentation.

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.

Qualifications

  • 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

Skills

Required:US and international post-market regulatory requirementsISO 14971Regulatory reportingCommunication and documentationCross-functional collaborationTool proficiency
Last updated Oct 5, 2026. Interested? Apply on the company site.

About Heartflow

Decisive Coronary Care

Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.

CCTA ResourcesRoadmap AnalysisFFRCT AnalysisPlaque AnalysisHeartflow OneHeartflow One PlatformMeasurable Impact
Company profileWebsite

More open roles at Heartflow