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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