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Project Manager II
Ref No.: 18-01584
Location: Waukegan, Illinois
Job Description
Comply with relevant US and International regulatory requirements through the timely review, documentation, and filing of ADD medical event reports. Ensure the safety and effectiveness of products in the field by interfacing with Global and Site Quality organizations conducting complaint investigations and highlighting potential medical, clinical and/or safety issues with ADD products.

Core Job Responsibilities
  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Review medical complaints, document filing decision rationale, and submit medical event reports in compliance with FDA regulations (21CFR803 and 21CFR820) and International Regulatory requirements within the required timeframes.
  • Ensure medical event file documentation is clear, concise, and adheres to compliance requirements.
  • Identify any non-conformances or potential non-conformances in a timely manner, ensure thorough documentation, and aid in the development of comprehensive CAPA strategies to prevent recurrence.
  • Provide subject matter expertise to the Customer Service and Support and Quality organizations responsible for identifying and resolving potential medical, clinical and /or safety issues.

Education Requirements
Bachelors Degree in a scientific discipline or Certification in Medical Technology (AMT, MLT, or similar) preferred.

Skills and Experience Required
  • Knowledge of regulations and standards affecting IVDs and Biologics.
  • Minimum of 3 years experience in either medical technology laboratory environment, or with IVD products through technical support, complaint handling, or similar work experience required.
  • Exemplary writing skills required; proficient use of MS Office and general IT system knowledge is a must.