Complaint Specialist (Medical Devices)

Location: Hybrid in Austin, Texas; work from the Austin office four times per week

Base salary: $61,000–$75,000 annually, plus bonus

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive solutions for diagnosing and managing coronary artery disease.

What you will do

• Assess, document, and manage product complaints from intake through timely review and closure.
• Perform regulatory reporting determinations and prepare Medical Device Reports and vigilance reports for FDA, EU, UK, and other global authorities.
• Review complaint investigations for completeness, root-cause rationale, and documentation quality.
• Escalate potential safety signals and support complaint trending, data requests, and management review.
• Support Quality Management System activities, including CAPA, NCRs, Health Hazard Evaluations, risk management, and audits.
• Partner with Customer Support and cross-functional teams to clarify events, gather information, and improve complaint-handling workflows.

Requirements

• Bachelor’s degree.
• 0–2 years of relevant medical device industry experience, preferably in complaint handling or post-market surveillance.
• Working knowledge of US and international post-market requirements, including FDA QMSR, 21 CFR 803 and 806, EU MDR, UK MDR 2002, Health Canada regulations, and Japan PMD Act.
• Knowledge of ISO 14971 risk management for medical devices and experience with software medical devices is preferred.
• Strong critical thinking, attention to detail, communication, documentation, and time management skills.
• Experience with Salesforce, electronic document management systems, Google Workspace, and Microsoft Office.

Culture & Benefits

• Hybrid work arrangement based in the Austin office.
• Opportunity to contribute to patient safety, regulatory integrity, and continuous quality improvement.
• Work in a fast-paced, adaptive environment with cross-functional collaboration.
• Base salary of $61,000–$75,000 annually plus bonus.