["Quality Specialist: MDR Remediation & eMDR Lead","Quality Specialist: MDR Remediation & eMDR Lead"]

You will review historical files, apply 21 CFR 803/820, determine if MDRs should have been filed, and coordinate with QA, Regulatory, and Operations to obtain missing data for defensible decisions; experience with eMDR is a plus.#J-18808-Ljbffr. Katalyst CRO in Springfield, IL, is seeking a detail‑oriented MDR remediation specialist to support retrospective complaint reviews and reportability assessments under FDA requirements.