Medline Mundelein, ILContract assignment length (1-2 years)
Pay rate: $28/hr on W2 without benifits
Hybrid work schedule (T, W, TH on-site. Mon & Fri work remote)(Complaint Specialist) - MDR Remediation Seeking contingent workers to support Medical Device Reporting (MDR) remediation activities, with a focus on retrospective complaint review reportability assessments under FDA requirements. Core Experience We Are Looking ForCandidates should have hands-on experience reviewing both historical and newly received product complaints to determine MDR reportability in compliance with FDA regulations (21 CFR Part 803) This role is remediation-driven and requires individuals who can apply current regulatory criteria and decision logic consistently across large complaint populations.
Key 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 (Quality, Regulatory, Operations, etc.) 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.
- Required Background & Skill SetA Bachelor's degree in a relevant field and at least 1+ year of experience in complaint handling, MDR evaluation, post-market surveillance, or similar regulated industry experience.
- 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, attention to detail, and the ability to apply updated regulatory logic consistently across many records.
- Preferred Experience 2+ years of MDR reporting or complaint remediation experience in a medical device, pharmaceutical, or healthcare environment.
- Experience working in remediation environments with aggressive deadlines and throughput expectations
- Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms
- Key Traits & Behavioral Attributes for Success:
- Strong attention to detail - Able to carefully review complaint records, medical narratives, and regulatory fields to ensure accuracy and audit-defensible MDR decisions
- Clear and professional communication skills - Comfortable documenting rationale, escalating questions, and collaborating cross-functionally to resolve missing or unclear data
- Quick learner - Able to rapidly understand internal procedures, MDR decision logic, and remediation workflows in a fast-paced environment
- Analytical and critical thinking skills - Capable of applying current MDR definitions and regulatory criteria consistently across large volumes of legacy complaints
- Time management and prioritization skills - Able to manage high-volume remediation work while meeting strict regulatory and remediation timelines
- Comfort working in structured, compliance-driven environments - Understands the importance of following procedures and producing consistent, traceable decisions
