Job Title: Complaint Specialist – MDR Remediation
Location: Mundelein, Illinois
Job Type: Contract (1–2 Years, Potential for Full-Time Conversion)
Openings: 10
Job Summary
We 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 Responsibilities
- Review historical complaint files as part of remediation efforts to verify completeness and reassess MDR reportability decisions
- Apply current FDA MDR regulations, definitions, and decision trees to legacy complaints
- Identify missing or incomplete complaint data and collaborate with cross-functional teams (Quality, Regulatory, Operations) to gather required information
- Prepare and submit MDRs through the FDA’s electronic MDR (eMDR) system when required
- Ensure compliance with FDA Quality System Regulations, including complaint handling under 21 CFR 820.198
- Maintain accurate documentation and ensure audit-ready, defensible decision-making
- Support high-volume remediation projects within strict timelines
Required Qualifications
- Bachelor’s degree in a relevant field
- Minimum 1+ year of experience in:
- Complaint handling
- MDR evaluation
- Post-market surveillance
- Regulated healthcare/medical device environment
- Working knowledge of FDA MDR regulations (21 CFR Part 803)
- Ability to interpret medical narratives, adverse events, and product complaints
- Experience handling high-volume documentation or remediation projects
- Strong analytical skills and attention to detail
Preferred Qualifications
- 2+ years of MDR reporting or complaint remediation experience
- Experience in medical device, pharmaceutical, or healthcare industries
- Familiarity with complaint management systems such as:
- SAP
- TrackWise
- Experience working in fast-paced remediation environments with strict deadlines
Key Skills & Competencies
- Strong attention to detail and accuracy
- Excellent written and verbal communication skills
- Ability to document clear, audit-defensible decisions
- Strong analytical and critical thinking abilities
- Ability to quickly learn regulatory processes and workflows
- Effective time management and prioritization skills
- Comfortable working in compliance-driven, structured environments
