Medline
Mundelein, IL
Medline in Mundelein, IL is seeking an Adverse Event Specialist to manage product complaint remediation and MDR reporting responsibilities. The role requires applying FDA 21 CFR 803 criteria and coordinating with cross-functional teams to ensure accurate reportability decisions.
You will review historical and new complaints, determine regulatory obligations, and submit MDRs via the FDA eMDR portal while collaborating with international contacts as needed.
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