Product Complaint Analyst I
Core
Analyze customer complaints to determine regulatory reportability, investigate events, and ensure compliance with Good Manufacturing Practices (GMPs) and Code of Federal Register (CFR) regulations.
Role type
Entry-level regulatory compliance analyst (medical devices)
Builds
Regulatory reports (MDRs, MedWatch, Vigilance) and compliance documentation for medical device safety
Domain
Medical devices / Healthcare / Regulatory affairs
Deliverable
dashboards & analysis
Required skills
Regulatory compliance analysis, Event investigation, Data collection and documentation, Medical device reporting, Coding of events, Written communication
Preferred skills
Complaint handling experience, Medical Device Report (MDR) writing, Electrophysiology domain knowledge, Trackwise system experience, Microsoft Office proficiency, Analytical problem-solving