MDR Specialist

Job Title: MDR Specialist Duration: 6 Months Contracts with possible extension/conversion Location: Mundelein, IL 60060 (HYBRID, 3 Day Onsite and 2 Day Remote) Pay Range: $28/hr - $30/hr Must Haves: 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 narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths Bachelor's degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field 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)