Responsible for Analysis of Product complaints for Medical Device Reportng (MDR). Work with the Regulatory group to prepare and submit MDR reports to Regulatory agencies, Identfying problems, and lead projects to improve processes, procedures, and/or practices; providing solutions including devising new approaches to Complaint Handling.• Good understanding of upcoming new EU Medical devices regulation for both medical devices (MDD) and in vitro diagnostic medical devices (IVDMD). ISO 13485:2016, 21 CFR 820• Complaints evaluation including adverse event reporting decisions.coding, initiasing Good Faith Effort (GFE) follow up for additiinal information and closure of records.• Evaluate complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary.• Knowledge of guidelines for medical device safety reporting requirements.• Good understanding of FDA Medical devices classification, including the Premarket approval process or PMA and Premarket Notification.Working on team track for technical investigation of a complaint and perform root cause analysis of the complaintI also hold experience in pharmaceutical manufacturing unit as QA specialist and currently working in IT company as A Senior Associate. I am a competent employee and can work independently. My expertise are Quality analyst, Documentation, Qualification following the cGMP, ICH Guidelines. Protocol review, integration with other departments - regulatory affairs, QA, DOP, medical devices, complaint handling SAP Trackwise Ms Excel, Product Training, Process Training, ServiceNow, complaint handling, risk management.