HeartFlow
Complaint Specialist
$61K–$75K
Austin, Texas +1 · Full-time · Posted Oct 1, 2026
- Location
- Austin, Texas
Austin, Texas, United States - Experience
- 0-2 years of relevant experience in the medical device industry; preferably in complaint handling or post-market surveillance.
- Education
- Bachelor’s degree
About the job
Manages medical-device complaints from intake through closure, evaluates regulatory reportability, and supports post-market surveillance and quality improvement.
What you'll do
- Assess, document, investigate, and close complaints; review investigation quality and escalate potential safety signals.
- Determine and document regulatory reporting obligations; prepare Medical Device Reports (MDRs) and vigilance reports for review and submission.
- Support complaint trending, quality-system activities, cross-functional escalations, and complaint-process improvements.
What they ask for
- Working knowledge of US and international post-market requirements, including FDA, EU, UK, Health Canada, and Japan regulations.
- Knowledge of ISO 14971.
- Bachelor’s degree.
- Experience with Salesforce, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office.
Nice to have
- Experience with software medical (Class II/III).
Pay
USD 61,000 to USD 75,000 base salary
Tools
21 CFR 820, ISO 13485, 21 CFR 803, 21 CFR 806, EU MDR, UK MDR 2002, ISO 14971, Salesforce
Model-written summary · the original posting is authoritative