Regulatory Compliance Specialist

4 weeks ago

Saint Paul, Minnesota, United States Blue Star Partners LLC Full time
Job Overview

The Regulatory Windchill Coordinator will play a crucial role in supporting the Regulatory Affairs team. Key responsibilities include validating and updating the Global Regulatory Library (GRL) approval record metadata using the Windchill system. This position requires strong analytical skills, attention to detail, and effective communication with global in-country affiliates to resolve data discrepancies.

Key Responsibilities:

  • Data Management & Validation:
    • Retrieve and organize regulatory approval records from Windchill for assigned countries using predefined search criteria.
    • Maintain Excel tracking sheets based on downloaded Windchill data, ensuring proper format for country-specific templates.
    • Perform metadata validation for approval records, including approval and expiration dates, legal manufacturers, certificate numbers, and models.
    • Update Windchill approval record fields to ensure compliance with the GRL naming conventions and regulatory requirements.
  • Communication & Issue Resolution:
    • Collaborate with in-country regulatory teams to resolve metadata discrepancies, missing approval records, or models.
    • Flag and communicate any expired records or metadata issues that need clarification for further resolution.
  • Reporting & System Updates:
    • Regularly update Windchill system records based on findings and communicate significant metadata out-of-syncs to the appropriate stakeholders.
    • Identify approval records requiring creation or multiple versions for reconciliation.

Requirements:

  • Minimum of 2 years of office experience, preferably in regulatory, data management, logistics, project management, or customer service roles.
  • Familiarity with regulatory processes or operations within the medical device industry is an advantage.
  • Data Analysis: Strong analytical skills for validating and managing metadata discrepancies in Excel and Windchill.
  • Attention to Detail: Proven ability to manage data with a high degree of accuracy, especially regarding regulatory compliance.
  • Problem-Solving: Capable of identifying issues and working cross-functionally to find solutions.
  • Software Proficiency: Experience with SAP, Windchill, or similar Product Lifecycle Management (PLM) systems is preferred. Familiarity with Excel and Business Objects reporting tools.
  • Communication: Strong interpersonal skills for collaboration with internal teams and global affiliates.

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