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Regulatory Windchill Coordinator

4 months ago


Fairfield, United States The Fountain Group Full time
Pay: $35-40/hr
Location: Sylmar, CA - first 2-3 weeks of training must be onsite and then may WFH the rest of the time with One Day In the Office.
Duration: 6 months; possible temp to perm for candidates willing to come onsite

Prefers candidates that are local to Sylmar so they may go into the office and also stand a better chance for conversion to FTE if performance supports this. Will accept Remote from outside of the Sylmar area ONLY if the candidate is Exceptional but won't be able to convert if/when the time comes.
This position is a shared role providing business support to the Medical Device division and collaborating with the Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service. Person will help in getting products to market through the use of SAP/PLM system to create shipping licenses, will conduct clean-up work and release products. Preferred or nice to have understanding of EUMDR (European Medical Device Regulations) for an understanding of compliance. Conducts Compliance checks, and works with Logistics partners and customers. Must feel comfortable with verbal and written communication as they will be communicating and working with others * Will be gathering data and executing such by conducting Data Analysis through the use of Excel pivot tables and vlookups - EXCEL IS A MUST HAVE. Will be pulling inventory and licensing reports and arriving at conclusions/providing solutions

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.