Labeling Specification Specialist

Support the development of medical device package labeling for the Cardiac Ablation Solutions business
Assist with label development in related businesses
Drive consistency and accuracy of format and content across all products and locations
Perform a wide variety of complex duties related to labeling
Interact with product design team to identify label requirements and content information
Develop label design and verification testing
Create and approve design documentation
Proofread and lead label review activities
Maintain and improve labeling processes and communicate to global stakeholders
Work with the project Packaging Engineer to create and release labeling components
Create or support development of various required labeling components
Develop plan, manage and monitor timelines and process of new and revised labeling
Review and release labeling for package labels
Identify potential improvements to the labeling development processes, tools and/or policies
Coordinate the translations of package labeling
Work with labeling system database(s) related to development of required label information
Create, review, and reproduce text required for labeling medical products
Monitor changes in labeling regulations in the US and/or abroad
Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools and/or policies

Degree in Packaging Engineering, Graphic Design, or Computer Science
Previous database driven labeling system experience (Loftware, Prisym 360, Transform)
Comfortable learning and using new computer systems and programs
Knowledge of US and international medical device regulations and standards, especially those related to labeling
Experience working with Adobe Illustrator and/or other graphic design programs
Experience in proofreading/editing
Experience in Agile and/or Windchill
Highly detail oriented
Experience working in business systems including Excel and other Microsoft Office programs
Experience working with global teams