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)