Title - Adverse Event Specialist Location - Mundelein, IL, 60060 Duration - 06 Months Pay Rate: $25.00 - $30.00/hr Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable) Job Description: 5 years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198) Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping Direct people management experience Experience supporting FDA inspections and CAPA activities