Complaint Specialist – MDR Remediation

Job Title: Complaint Specialist – MDR RemediationLocation: Mundelein, IllinoisJob Type: Contract (1–2 Years, Potential for Full-Time Conversion)Openings: 10Job SummaryWe are seeking Complaint Specialists to support Medical Device Reporting (MDR) remediation activities. This role focuses on retrospective complaint review and MDR reportability assessments in compliance with FDA regulations (21 CFR Part 803).The ideal candidate will have hands-on experience reviewing both historical and new complaint records, applying regulatory decision logic, and ensuring accurate and compliant reporting.Key ResponsibilitiesReview historical complaint files as part of remediation efforts to verify completeness and reassess MDR reportability decisionsApply current FDA MDR regulations, definitions, and decision trees to legacy complaintsIdentify missing or incomplete complaint data and collaborate with cross-functional teams (Quality, Regulatory, Operations) to gather required informationPrepare and submit MDRs through the FDA’s electronic MDR (eMDR) system when requiredEnsure compliance with FDA Quality System Regulations, including complaint handling under 21 CFR 820.198Maintain accurate documentation and ensure audit-ready, defensible decision-makingSupport high-volume remediation projects within strict timelinesRequired QualificationsBachelor’s degree in a relevant fieldMinimum 1+ year of experience in:Complaint handlingMDR evaluationPost-market surveillanceRegulated healthcare/medical device environmentWorking knowledge of FDA MDR regulations (21 CFR Part 803)Ability to interpret medical narratives, adverse events, and product complaintsExperience handling high-volume documentation or remediation projectsStrong analytical skills and attention to detailPreferred Qualifications2+ years of MDR reporting or complaint remediation experienceExperience in medical device, pharmaceutical, or healthcare industriesFamiliarity with complaint management systems such as:SAPTrackWiseExperience working in fast-paced remediation environments with strict deadlinesKey Skills & CompetenciesStrong attention to detail and accuracyExcellent written and verbal communication skillsAbility to document clear, audit-defensible decisionsStrong analytical and critical thinking abilitiesAbility to quickly learn regulatory processes and workflowsEffective time management and prioritization skillsComfortable working in compliance-driven, structured environments