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