Complaint Specialist - Medical Devices (Mundelein)

Job Title: Complaint Specialist – MDR Remediation

Location: Mundelein, IL

Employment Type: Full-Time

Position Overview

We are seeking detail-oriented Complaint Specialists to support Medical Device Reporting (MDR) remediation activities. This role focuses on retrospective review of complaint records to ensure compliance with FDA reporting requirements, specifically under 21 CFR Part 803. The position is highly analytical and suited for individuals experienced in regulatory review, complaint handling, and post-market surveillance within regulated industries.

Key Responsibilities

• Review historical complaint files to verify completeness and reassess MDR reportability decisions.
• Apply FDA MDR regulations and decision-making criteria to determine if events are reportable.
• Identify gaps or missing data in complaint records and collaborate with cross-functional teams (Quality, Regulatory, Operations) to resolve them.
• Prepare and submit MDRs via 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 rationale for all decisions in line with audit and compliance expectations.
• Manage high-volume workloads within strict remediation timelines.

Required Qualifications

• Bachelor’s degree in a relevant field.
• Minimum 1+ year of experience in complaint handling, MDR evaluation, post-market surveillance, or similar regulated environment.
• Working knowledge of FDA MDR regulations (21 CFR Part 803) and complaint handling requirements.
• Strong ability to interpret medical narratives and assess adverse event reportability.
• Experience reviewing large volumes of documentation or participating in remediation projects.
• Excellent analytical skills and attention to detail.

Preferred Qualifications

• 2+ years of MDR reporting or complaint remediation experience in medical device, pharmaceutical, or healthcare industries.
• Experience working in fast-paced remediation environments with strict deadlines.
• Familiarity with complaint management systems such as SAP, TrackWise, or similar tools.

Key Competencies

• High attention to detail and accuracy
• Strong written and verbal communication skills
• Ability to quickly learn regulatory processes and internal workflows
• Critical thinking and decision-making skills
• Effective time management and prioritization
• Comfort working in structured, compliance-driven environments