Address
Form of workThe Regulatory 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.
