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