This position works independently but with general supervision to prepare and submit Medical Device Reports (MDRs) to global Health Authorities. Ensures global reportable complaints for LifeScan are processed and submitted accurately, and on time to global Health Authorities. Acts as a resource for Customer Service regarding Potential Reportable complaints. Main responsibilities may include: * Using discretion and independent medically-based judgment: Reviews, evaluates, classifies potential reportable complaints as adverse event, product malfunction or rule-outs for both U.S. and International affiliates. * Evaluates global potential reportable complaints demonstrating sound judgment to determine if the reporting requirements for global medical device reports are met. * Responsible for timely regulatory reporting, collaboration and teaming, and accurate/precise documentation. * Processes MDR’s/MDV's and rule-outs within the Diabetes Care Complaint System and file MDR's/MDV's with global Health Authorities as required. * Notify the appropriate international representatives when reports must be filed with their local health authorities. * Communicates with global customer/technical service representatives and with the end-users when clarification is required. Required criteria include: * Degree in health–related science or life science with experience in a medical field (RN, CDE, DSN, BSN, BPHS, MSN, MHS, DNP, BSC, MSc…etc) patient education. * Sound business judgment and ability to make independent decisions to ensure compliance with FDA, MEDDEV and global Health Authority reporting requirements. * Excellent verbal and written communication skills in English. * Excellent attention to detail. * Excellent interpersonal, problem-solving, and organizational skills. * Proficient in the use of technology including keyboarding, PC’s, Internet, word processing, email functionality, etc