Location: Maple Grove, MN
Duration: 6-12 months

Position Responsibilities

  • Ensures compliance to internal and external labeling requirements, specifically for EU MDR
  • Completes artwork redlines (labels, Directions for Use- DFU/IFU, and cartons)
  • Updates label template specifications
  • Updates labels using Global Labeling System (Prysm ID software)
  • Aids internal labeling project specialist in labeling requirements gap assessment
  • Gathers source documentation to provide traceability from documents and reports to labeling elements
  • Coordinates with packaging on changes due to label stock and/or packaging updates
  • Coordinates with cross-functional teams to implement required changes
  • Holds cross-functional team reviews
  • Attends core team meetings for labeling work streams
  • Coordinate requests with packaging graphics; send work requests to graphics group

Basic Qualifications

  • AA Degree or equivalent work experience in related discipline
  • Medical device or pharmaceutical experience
  • Technical communications or labeling experience
  • Extremely detail oriented
  • Working knowledge of MS Office (Word and Excel especially) and any label system
  • Excellent oral/written communication skills
  • Ability to do independent research and find solutions
  • Self-starter and fast learner
  • Strong interpersonal skills
  • Ability to manage multiple tasks with shifting priorities
  • Document management system experience
  • Experience with Adobe Acrobat

 


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