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Regulatory Specialist I

Rosemont, IL 60018

Posted: 04/08/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 604426 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges between $35-40/hr
Experience: 0-2 years regulatory experience and/or relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

  • Knowledge of regulations and standards affecting IVDs and/or biologics
  • Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

  • Responsible for implementing and maintaining the effectiveness of the quality system.
  • Supports manufacturing/operations day to day activities for change control.
  • Provides consultation/advice to regulatory specialist for change control and product development.
  • Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.
  • Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
  • Handles regulatory activities involved in documentation, labeling, field support.
  • Applies regulatory and technical knowledge to a wide variety of complex work assignments.
  • Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
  • Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.
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