Quality Specialist

Katalyst CRO; Mundelein (IL); On-site; USD 70,000 - 110,000; Full time

Job summary

Katalyst CRO in Mundelein, IL, seeks an MDR remediation reviewer to evaluate historical complaint files under FDA requirements. The role focuses on applying MDR definitions and decision trees to legacy cases to determine reportability and to identify missing data for defensible decisions.

You will coordinate with Quality, Regulatory, Operations and other teams to obtain necessary information and, when remediation identifies reportable events, prepare and submit MDRs through the FDA’s electronic

Qualifications

• Bachelor's degree in a relevant field is preferred but not required.
• 1+ year of experience in complaint handling, MDR evaluation, or similar regulated industry experience.
• 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.

Responsibilities

• Review historical complaint files to reassess MDR reportability.
• Apply FDA MDR definitions and decision trees to legacy complaints to determine whether an MDR should have been filed.
• Identify missing data and coordinate with Quality, Regulatory, Operations, and other teams 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.
• Ensure compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, within strict remediation timelines.
• Review both historical and newly received product complaints for MDR reportability in compliance with FDA regulations (21 CFR Part 803).
• Interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.
• Manage high volume documentation reviews or participate in large-scale remediation or retrospective review projects.

Skills

Analytical skills

Attention to detail

Medical narratives interpretation

Adverse event analysis

Regulatory compliance

Fast-paced environment

Education

Bachelor's degree preferred

Tools

SAP

TrackWise

Job description

Summary

Support remediation activities with a focus on retrospective complaint review reportability assessments under FDA requirements.

• 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 with Quality, Regulatory, Operations, and other teams 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.
• Hands-on experience reviewing both historical and newly received product complaints for MDR reportability in compliance with FDA regulations (21 CFR Part 803).
• 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 and attention to detail.
• Ability to work in a fast-paced environment.

Summary

Support remediation activities with a focus on retrospective complaint review reportability assessments under FDA requirements.

Roles & 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 with Quality, Regulatory, Operations, and other teams 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.
• Hands-on experience reviewing both historical and newly received product complaints for MDR reportability in compliance with FDA regulations (21 CFR Part 803).
• 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 and attention to detail.
• Ability to work in a fast-paced environment.

Education & Experience

• A Bachelor's degree in a relevant field is preferred but not required.
• At least 1+ year of experience in complaint handling, MDR evaluation, or similar regulated industry experience.
• 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.