Regulatory Compliance Coordinator for Medical Devices

7 days ago


Fairfield, California, United States Blue Star Partners LLC Full time
Job Overview

We are seeking a skilled Regulatory Compliance Coordinator to support our Medical Device team in Fairfield, CA.

Salary: $40-$45/hour (Hours over 40 will be paid at Time and a Half)

About the Role

The Regulatory Compliance Coordinator provides critical support to our Regulatory Affairs team by validating Global Regulatory Library (GRL) approval record metadata. This role involves collaboration with various teams to facilitate market release of products using the SAP/PLM system. Responsibilities include creating shipping licenses, conducting compliance checks, and performing clean-up tasks.

This position requires strong communication skills, both verbal and written, to effectively work with partners and customers.

Key Responsibilities
  • Data Analysis: Gather and analyze data using Excel pivot tables and VLOOKUPs to ensure accuracy and efficiency.
  • Regulatory Records Management: Use Windchill application to pull regulatory approval records for assigned countries, create Excel tracking sheets, and validate metadata to ensure consistency.
  • Metadata Validation: 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: Resolve discrepancies in approval records by communicating with in-country affiliates and report any issues.
  • Compliance Checks: Conduct compliance checks and work with logistics partners and customers to ensure regulatory adherence.
Requirements
  • 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.


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