Regulatory Windchill Coordinator - Hybrid - Blue Star Partners LLC

Job Title: Regulatory Windchill Coordinator
Location: Fairfield, CA – Hybrid (1 day per week onsite) – Local candidates only
Period: 08/02/2024 to 12/31/2024 – possibility of extension
Hours/Week: 40 hours 
Rate: $40-$45/hour (Hours over 40 will be paid at Time and a Half)
Contract Type: W-2

 
Scope of Services:

The Regulatory Windchill Coordinator provides vital support to the Regulatory Affairs team by validating Global Regulatory Library (GRL) approval record metadata. This position involves collaboration with the Medical Device division, Supply Chain Group, Regulatory Affairs, Clinical, and Customer Service teams to facilitate the market release of products using the SAP/PLM system. Responsibilities include creating shipping licenses, conducting compliance checks, and performing clean-up tasks. The preferred candidate will understand EUMDR (European Medical Device Regulations) to ensure compliance. The role requires strong communication skills, both verbal and written, to effectively work with various partners and customers.

 
Role, Responsibilities, and Deliverables:

• Data Analysis: Gather and analyze data using Excel pivot tables and VLOOKUPs.
• Regulatory Records Management: Use Windchill application to pull regulatory approval records for assigned countries, create Excel tracking sheets, and validate metadata.
• Metadata Validation: Leverage tracking sheets and templates to identify discrepancies in metadata fields such as approval dates, expiration dates, models, legal manufacturer, manufacturing facilities, and certificate numbers.
• Windchill Updates: Update Windchill fields to match approval records and ensure consistency with GRL naming conventions.
• Communication and Clarification: Identify and resolve discrepancies in approval records by communicating with in-country affiliates. Report any issues such as expired approval records, incorrect approvals, or missing models.
• Compliance Checks: Conduct compliance checks and work with logistics partners and customers to ensure regulatory adherence.

 
Qualifications:

• Education: High school diploma required.
• Excellent problem-solving, communication, organization, and data analysis skills.
• Proficiency in Excel, including pivot tables and VLOOKUPs, is essential.
• Ability to prioritize daily tasks and maintain flexibility to adapt to changing priorities.
• Capability to work both independently and as part of a team.
• Ability to follow instructions and work with a mentor.
• Experience in project management and customer service is preferred.
• Understanding of EUMDR (European Medical Device Regulations) for compliance purposes.
• Experience with SAP/PLM systems and regulatory approval processes.