Compliance Specialist Jobs in Illinois

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
• Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teams
• Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping
• Proficiency with Office Suite and complaint management systems such as SAP, TrackWise, or similar platforms
• Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field

Compensation:

• Range: $25-30/hr

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 off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually - as applicable.