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Regulatory Coordinator Saint Louis, MO 
Posted:  11/14/2017
Category:  Administrative
Job Type:  Contractor
Minimum Experience:  -
Required Education:  Associate (AA, AS...)
Job Description

One of our customers has a Regulatory Coordinator job.
The Regulatory Coordinator handles documentation management including MSDS for raw materials, compiling information for compliance projects and maintains electronic regulatory files. In addition, the position is responsible for obtaining Certificates of Free Sale, translation of key regulatory documents and registration fees for both domestic and international regulatory filings. The Regulatory Coordinator provides responses to customer requests for regulatory product information and tracks and updates regulatory information.

Job Requirements

Experience Requirements:
  • Good communication, prioritization and organizational skills
  • Previous experience in a regulated environment is preferred
Essential Job Functions:

1. Manage & control raw material MSDS documentation for entire location. Identify and provide updates on modifications and changes to MSDS to allow RA staff to review and conduct risk assessment for finished products.

2. Compile quarterly regulatory compliance information for Management Review.

3. Maintain document files related to EPA registrations, CE Marking and Technical files for EU medical devices manufactured in St. Louis, literature review files for marketing documentation reviewed by RA and Regulatory files associated with FDA inspections, MDRs and product recalls.

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