Jr. MDR complaint Specialist

Jr. MDR complaint Specialist

Mundelein, IL (Hybrid)

12+ months Contract

Job Description;

Work Environment

Work is performed in an office setting within a regulated medical device or pharmaceutical environment. The role follows a hybrid schedule, with on-site work required on Tuesday, Wednesday, and Thursday, and remote work from home on Monday and Friday. The position involves extensive computer-based review of electronic medical device records and use of complaint management systems such as SAP, TrackWise, or similar platforms. The environment is fast-paced, deadline-driven, and focused on large-scale remediation and documentation accuracy, offering a long-term contract opportunity with the potential to transition to a direct role based on performance.

Job Type & Location

This is a Contract position based out of Mundelein, IL.

Job Description

The MDR complaint supports remediation activities with a primary focus on retrospective complaint review and MDR reportability assessments in alignment with FDA requirements. This role involves reviewing historical and newly received product complaints, reassessing prior reportability decisions, and ensuring that all MDR submissions comply with 21 CFR Part 803 and related FDA Quality System Regulations. The position is ideal for someone who is detail-oriented, comfortable managing high volumes of documentation, and experienced in working within a regulated medical device or pharmaceutical environment.

Responsibilities

·         Review historical complaint files as part of remediation or retrospective review efforts to verify completeness and reassess MDR reportability decisions.

·         Evaluate newly received product complaints to determine MDR reportability in compliance with FDA regulations (21 CFR Part 803).

·         Apply current FDA MDR definitions, criteria, and decision trees to legacy and new complaints to determine whether an MDR should have been filed or should be filed.

·         Identify missing or incomplete data within complaint records and collaborate cross-functionally with Quality, Regulatory, Operations, and other teams to obtain necessary information for defensible decisions.

·         Prepare and submit MDRs through the FDA’s electronic MDR (eMDR) system when remediation activities identify reportable events.

·         Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, while meeting strict remediation timelines.

·         Manage and prioritize high volumes of documentation reviews to support large-scale remediation or retrospective review projects.

·         Maintain accurate, clear, and complete documentation to support audits, inspections, and internal quality system requirements.

·         Interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.

·         Contribute to continuous improvement of complaint handling and remediation processes by sharing insights and observations from review activities.

Essential Skills

·         At least 1+ year of experience in complaint handling, MDR evaluation, or similar experience within a regulated industry.

·         Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements.

·         Understanding of FDA Quality System Regulations, including 21 CFR 820 and complaint handling under 21 CFR 820.198.

·         Hands-on experience reviewing product complaints to determine MDR reportability in compliance with FDA regulations.

·         Experience managing high-volume documentation reviews or participating in large-scale remediation or retrospective review projects.

·         Strong ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.

·         Strong analytical skills and a high level of attention to detail.

·         Ability to work effectively in a fast-paced environment and meet aggressive deadlines.

·         Proficiency with electronic medical device records and documentation practices.

·         Effective communication and collaboration skills for working with cross-functional teams.

Additional Skills & Qualifications

·         Bachelor’s degree in a relevant field is beneficial but not required.

·         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.

·         Experience supporting remediation or retrospective review efforts for regulatory compliance.

·         Demonstrated ability to maintain organized records and documentation in support of audits and inspections.