Regulatory Compliance Professional

1 week ago


Kalamazoo, Michigan, United States Eurofins USA PSS Insourcing Solutions Full time

About Us:

Eurofins USA PSS Insourcing Solutions is a leading international life sciences company providing analytical testing services to clients across multiple industries.

We work with the biggest companies in the world to ensure their products are safe, ingredients authentic and labelling accurate. Our team is dedicated to making life and our environment safer, healthier and more sustainable.


Job Responsibilities:

  • Ensure accurate data entries for Human Health Products
  • Collaborate with the Global Product Dictionary Admin team to meet Global Diagnostics system needs
  • Facilitate release of product shipments within the ERP system when Regulatory approvals are obtained– Regulatory Affairs Documentation Support:
  • Coordinate with Regulatory Affairs Managers and Manufacturing Compliance Members to obtain legalization of documents required for International Markets
  • Gather manufacturing documents and other documents needed to support registration as requested by the regulatory team
  • Upload required documents into the Enterprise-wide Document Management System
  • Maintains information systems (electronic and paper) for regulatory information– Assist in the development of instructional guidance's and processes, as applicable – Provide status updates on tasks as appropriate
  • Label Backup Support (in support of the primary diagnostic label lead):
  • Liaise with Regulatory Affairs managers, icRAMS and the Client Artwork Center to assure compliance with global diagnostics labelling requirements
  • Manage study risk assessments process including risk assessment intake, assignment, compilation, signatures, and final archival

What We Offer:

  • Excellent full time benefits including comprehensive medical coverage, dental, and vision options
  • Life and disability insurance
  • 401(k) with company match
  • Paid vacation and holidays
  • Yearly goal-based bonus & eligibility for merit-based


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