Quality Specialist

Job Title

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

Roles and 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.