Quality Specialist
Katalyst Healthcares and Life Sciences
Summary :
Support remediation activities with a focus on retrospective complaint review reportability assessments under FDA requirements.
Roles & Responsibilities :
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.
- 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.
Vacancy posted 4 days ago
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