Job Description :
Competencies
EIS: Medical Device and Regulations

Essential Skills
Complaint analyst who processes complaints and determines reportability decisions. The analyst will review complaints, select complaint codes, decide if an IR needs to be created per procedure, follow up with customers for additional information, determine reportability decision and draft reports.

Desirable Skills
Excellent communication, interpersonal and organizational skills.

Role Description:
Responsibilities include medical review of complaint files for reportability to a regulatory agency, escalation of reports to management, and possible filing the event to a regulatory agency. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Monitors, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.