Product Complaint Analyst II
Core
Analyze customer complaints for the Urology portfolio to determine regulatory reportability and coordinate activities with internal and field customers.
Role type
Medical device compliance analyst
Builds
Regulatory reports and compliance documentation for medical devices
Domain
Medical devices / Urology
Required skills
Regulatory reporting, complaint investigation, clinical knowledge application, data gathering, written communication, coding of events
Preferred skills
Critical thinking, time management, biology/health sciences/engineering background
Technologies
None stated
Responsibilities
Review complaint communications for regulatory reportability and patient safety impact; Investigate complaints by gathering data from clinical staff, field reps, and lab results; Establish regulatory reportability decisions using investigation models; Write Medical Device Reports (MDRs) and vigilance reports; Apply codes to events and review investigations with engineering and lab staff; Compose written communications detailing clinical observations and corrective actions to physicians and customers