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We are now looking for an experienced consultant within UDI Data Support to support ongoing and future UDI (Unique Device Identification) activities within a global medical device organization.
Job Responsibility
Interpret and translate global UDI regulatory requirements into business and data specifications
Support the development of plans related to UDI data preparation and submissions
Coordinate implementation progress, stakeholder alignment, and issue resolution across functions
Support work related to data readiness, governance, and consistency in line with current and future UDI data models
Support the creation of UDI-related processes and documentation within the quality management system (QMS)
Support and potentially educate internal stakeholders and departments regarding UDI-related processes and requirements
Work closely with stakeholders across Regulatory Affairs, R&D, IT, Packaging Development, Master Data, and Commercial teams
Contribute to data-driven processes and system-related initiatives connected to UDI activities
Support reporting, presentations, and documentation related to ongoing projects and regulatory requirements
Participate in process improvements and help ensure effective collaboration across functions and geographies
Requirements
Experience working with regulatory, technical, or data-driven processes
Strong communication and stakeholder management skills
Experience working in cross-functional and international environments
Ability to work in a structured and organized way with strong attention to detail
Experience creating documentation, reports, presentations, or QMS-related material
Good understanding of business processes and system support
Nice to have
Experience within Medical Devices, Regulatory Affairs, or R&D
Experience working with UDI frameworks or UDI implementation
Experience related to master data or governance processes
Experience collaborating with IT teams on system-related initiatives