Complaint Specialist

The role

The Complaint Specialist manages product complaints from intake through closure. This role involves evaluating, documenting, and assessing reports for regulatory reportability to protect patient safety and regulatory integrity.

What you will do

• Assess reports from multiple customer feedback channels to identify deficiencies and manage closure.
• Perform and document regulatory reporting determinations.
• Prepare Medical Device Reports and vigilance reports for global regulatory authorities.
• Review complaint investigations for completeness and root cause rationale.
• Escalate potential safety signals when appropriate.
• Assist with complaint data requests to support trending and management review.
• Support Quality Management System activities including CAPA, NCR, HHE, risk management, and audits.
• Partner with Customer Support as a liaison for complaint escalations.
• Help maintain complaint handling tools and procedures to streamline workflows.

Required qualifications

• Bachelor’s degree
• 0-2 years of relevant experience in the medical device industry
• Working knowledge of US and international post-market requirements including FDA 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDR, UK MDR 2002, Health Canada Medical Devices Regulations, and Japan PMD Act
• Knowledge of ISO 14971
• Strong critical thinking skills
• Great attention to detail
• Excellent communication, documentation, and time management skills
• Ability to work independently in a fast-paced, adaptive environment
• Ability to collaborate well within a team
• Experience with Salesforce, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office

Nice to have

• Experience in complaint handling or post-market surveillance
• Experience with software medical (Class II/III)

About the company

Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using AI-driven technology. It is a publicly traded company cleared for use in the US, UK, Europe, Japan and Canada.