Illinois Licensed Medical Reviewer

Job Summary

A company is looking for a Medical Reviewer/Safety Reviewer III.

Key Responsibilities

• Perform medical review of Case Report Forms (CRFs), resolve queries, and write data addenda
• Support periodic and individual medical device safety reporting and PI site notifications
• Contribute to risk/benefit assessments and assist with documentation for FDA submissions

Required Qualifications

• Bachelor's degree in Nursing or Biomedical Engineering (RN required; advanced degree preferred)
• 3-4 years' experience in the medical device industry
• Knowledge of FDA, EU-MDR, and global device safety regulations
• Experience assessing adverse events and conducting device risk management
• Proficiency in Microsoft Word, Excel, and Windows