Labeling Specialist III

Duration: 12+ Months

• The EU MDR Labeling Lead will be responsible for supporting and managing tasks related to EU MDR Labelling updates and requirements for medical device labels, packaging, Instructions for Use (IFUs), Patient Implant Cards (PIC), and Patient Information Leaflets (PIL).
• This candidate must have experience leading and executing within all areas of the Labeling Workstream, from working with Cross-functional Teams on content development, artwork creation & validated approval workflows to site implementation.
• The EU MDR Labeling Lead will lead project meetings, drive coordination, and execute all related work activities for MDR and associated projects in the Labeling Workstream.
• Work with core product Teams to develop labeling content holistically for all levels/layers of labeling in multiple product families/portfolios for MDR applications.
• Coordinate and consolidate labeling content changes provided by cross-functional partners, finalize label redlines, and execute artwork updates through the workflow management system shared with the Graphics Team.
• Manage artwork labeling content approval process workflows in a validated approval system.
• Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across EU MDR project teams and sites for all impacted labeling components.
• Support label content translation and verification process
• Develop knowledge and understanding of EU MDR labeling requirements and client GSOPs and apply them to all future EU MDR labeling projects.
• Maintain and ensure adherence to all EUMDR labeling project timelines and deliverables.
• Must have proven success working with multiple cross-functional teams.

• Strong organizational and project management skills
• Aptitude for learning new software and systems.
• Ability to acknowledge issues or problems and work quickly to identify solutions as both an individual contributor and team contributor.
• Knowledge of core Microsoft Office software including Word, PowerPoint, Excel, Team/SharePoint
• Knowledge/Background in artwork creation/management for print production and manufacturing is a plus.

• Design and inspect all labels on product packages to ensure they comply with industry or government regulations.
• Your responsibilities include the design of artwork and labels that clearly indicate what type of product is included in the package and ensuring they comply with all rules regarding warnings, proper directions, proofs of purchase, and other information.
• You develop tools to manage the development and design of new labeling and modify standard operating procedures when regulations change. 7+ years of experience.

Education: HSD

Shift: Monday -Friday