Specializing in Pharmacovigilance, Regulatory Reporting, Product Complaint Investigation, Technical Support and Information Technology. Extensive Complaint Investigative experience in Medical Devices including Drug delivery, Ophthalmics, Diagnostics, Surgical Systems and instruments, In Vitro Diagnostic Medical Devices and including combination products. BTC and OTC Drugs. Analyzes customer complaints for both SI and Malfunction. Document and maintain records of all complaint investigations in accordance with 21CFR 820.198. Creation, investigation and reporting of Medical Device Reports for submission to FDA if incident meets reportable criteria for both Malfunction and Serious Injury. Good understanding of upcoming new EU Medical devices regulation for both medical devices (MDD) and in vitro diagnostic medical devices (IVDMD). Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803. Knowledge of hospital environment, point of care business and related regulatory environment. Knowledge of guidelines for medical device safety reporting requirements. Knowledge of FDA complaint regulations for drug products, biologics and medical devices. Accurately documents AE case data for Clinical studies, Drugs, Medical devices, biologics and including Oncological drugs. Strong understanding of GCP, GMP, GDP, GLP, ICH Guidelines and FDA regulations. Good understanding of FDA Medical devices classification, including the Premarket approval process or PMA and Premarket Notification or 510K. Performs all aspects of data entry including coding of events, determination of labeling, reportability, and completing cases within required timelines. Responsible for maintaining the quality processes associated with regulatory reporting and its procedures/controls to ensure that all MDR reportable complaints are processed and submitted in accordance with established company procedures and worldwide regulations and standards. Responsible for processing complaint files globally from Intake status to closure; including coding for USA, EU, China, Japan, Latin America, Australia and close files appropriately within 60 to 90 days to meet metrics. Responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.). Ensure accurate documentation of evaluation and investigation result of the complaint file; including literature files, and clinical files. Request SQM Review when complaint is confirmed.