Product Complaint Analyst III
Core
Analyze customer complaints to determine regulatory reportability and coordinate activities with internal teams and field representatives for urology medical devices.
Role type
Senior Product Complaint Analyst (Medical Devices)
Builds
Regulatory reports (MDRs, MedWatch, Vigilance) and clinical investigation records
Domain
Medical Devices / Urology / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Medical device complaint handling, regulatory compliance assessment, clinical knowledge application, event investigation, regulatory reporting, coding of events, written communication
Preferred skills
SAS, Power BI, TrackWise, scientific literature review
Responsibilities
Review complaint communications for regulatory compliance and patient safety impact; Investigate complaints by gathering data from clinical staff and laboratory analyses; Establish regulatory reportability decisions using decision models; Develop and modify decision models for compliance; Write Medical Device Reports and other regulatory submissions; Apply codes to events for product performance records; Compose written communications detailing clinical observations and corrective actions; Review and approve team work.