Quality Specialist

Summary Support remediation activities with a focus on retrospective complaint review reportability assessments under FDA requirements. Review historical complaint files as part of a remediation or retrospective review effort to verify completeness and reassess MDR reportability decisions. Apply current FDA MDR definitions, criteria, and decision trees to legacy complaints to determine whether an MDR should have been filed. Identify missing or incomplete data within complaint records and work cross-functionally with Quality, Regulatory, Operations, and other teams to obtain necessary information for a defensible decision. Prepare and submit MDRs through the FDA's electronic MDR (eMDR) system when remediation identifies reportable events. Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, within strict remediation timelines. Hands-on experience reviewing both historical and newly received product complaints for MDR reportability in compliance with FDA regulations (21 CFR Part 803). Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements. Strong ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability. Experience managing high volume documentation reviews or participating in large-scale remediation or retrospective review projects. Strong analytical skills and attention to detail. Ability to work in a fast-paced environment. Summary Support remediation activities with a focus on retrospective complaint review reportability assessments under FDA requirements. Roles & Responsibilities Review historical complaint files as part of a remediation or retrospective review effort to verify completeness and reassess MDR reportability decisions. Apply current FDA MDR definitions, criteria, and decision trees to legacy complaints to determine whether an MDR should have been filed. Identify missing or incomplete data within complaint records and work cross-functionally with Quality, Regulatory, Operations, and other teams to obtain necessary information for a defensible decision. Prepare and submit MDRs through the FDA's electronic MDR (eMDR) system when remediation identifies reportable events. Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, within strict remediation timelines. Hands-on experience reviewing both historical and newly received product complaints for MDR reportability in compliance with FDA regulations (21 CFR Part 803). Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements. Strong ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability. Experience managing high volume documentation reviews or participating in large-scale remediation or retrospective review projects. Strong analytical skills and attention to detail. Ability to work in a fast-paced environment. Education & Experience A Bachelor's degree in a relevant field is preferred but not required. At least 1+ year of experience in complaint handling, MDR evaluation, or similar regulated industry experience. 2+ years of MDR reporting or complaint remediation experience in a medical device or pharmaceutical environment is preferred. Experience working in remediation environments with aggressive deadlines and throughput expectations. Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms. #J-18808-Ljbffr