Events Specialist

**Contract-Role** Must Have: 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 Ability to evaluate complaint narrativ

We are Hiring - Adverse Event Specialist Location: Mundelein, IL (Hybrid Onsite Tuesday Thursday, Remote Monday & Friday) Duration: 3-6 months Pay Range: 25-30/hr We are seeking an Adverse Event Specialist to support product complaint reviews and Medical Device Reporting (MDR) activities. This role will be responsible for evaluating complaints, determining reportability, and ensuring compliance with FDA regulations and internal quality standards. Responsibilities: Review product complaints and

Title: Adverse Event Specialist Location: Hybrid Mundelein, IL (Onsite Tuesday Thursday; Remote Monday and Friday) Duration: 3 6 months Pay Range : $28 to $30 per hour 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 , pa

Job Description Support remediation activities with a focus on retrospective complaint reviewreportability assessments under FDA requirements. 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 comp