Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-ABT-77392
  • Location: Des Plaines Illinois (IL) 60018
  • Posted Date: 05/14/2019
  • Duration: 6 Months
  • Status: Open
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  Job Description

2+ years’ regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

Skills: 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.

DUTIES:

  • 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.