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Regulatory Affairs Manager

Job Description

Alchemy are currently partnering with a global technology firm who are looking to recruit a Regulatory Affairs Manager to be based onsite in Round Lake, IL

  • Good understanding of Medical product lifecycle, standardization, Change management process
  • Responsible for coordinating the collection and maintenance of all required UDI data
  • Holds regular meetings with stakeholders to ensure compliance with on-going UDI data submission and deadlines
  • Follows UDI communication standards to provide clear direction and understanding of purpose, requirements and expectations
  • Ensures UDI approvers complete the required system training before initiating UDI Data
  • Independently reviews the UDI Data and Reviews discrepancy reports and discussing with the respective stakeholder resolving the issue
  • Prepares approval documentation such as Paper signature memo
  • Routes data for approval in PLM (Product Life-cycle Management system)
  • Supporting respective team with UDI data transmission
  • Performs UDI data document formatting
  • Keeps UDI Process Project Management Traceability and History tools and systems up-to-date as established by UDI Manager
  • Close the assigned change control UDI tasks
  • Experience in PLM tools – ERP, Teamcenter, SAP and any other PLM Tools
  • Excellent skills in MS Office (Word, Excel & PowerPoint) and MS Access tool