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Regulatory Windchill Coordinator

Company: Horizontal Talent
Location: Minnetonka
Posted on: August 5, 2022

Job Description:

Position Summary:

  • The Regulatory Windchill Coordinator provides support to the Regulatory Affairs team and is responsible for validating Global Regulatory Library (GRL) approval record metadata. Essential Functions:
    • Using Search criteria to pull Regulatory Approval records information for assigned countries via the Windchill application.
    • Downloading the Windchill information to create Excel tracking sheets.
    • Leverage the Excel tracking sheets and Country Specific Approval record templates to validate the Metadata of the individual approval records.
    • Identify out of syncs between specific metadata fields and the approval records.
    • Update fields in Windchill to match the approval records; approval dates, expiration dates, models, legal manufacturer and manufacturing facilities, certificate number.
    • Update the Windchill approval name to match the GRL naming convention.
    • Identify approval records that need clarification to reconcile the information and communicate with the contact for the in-country affiliates for resolution. Communicate any of the following:
      • approval records that are now considered expired; any approval records that do not appear to be approval records; models that are not in Windchill that will need to be created; examples of multiple approval records with the same information; other out of syncs that are not outlined above. Qualifications:
        • High school diploma, Ability to learn a system and navigate it.
        • Initiative to ensure work is done accurately and completely.
        • Organized and detailed orientated.Additional Info:
          • Looking for individuals with some medical device for this position in product release.
          • The individual should be detail oriented, able to follow complex work instructions, and be conscientious about their work.
          • Experience in Regulatory is a plus.

Keywords: Horizontal Talent, Minnetonka , Regulatory Windchill Coordinator, Other , Minnetonka, Minnesota

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