Labeling Coordinator (425891)

Create labels, package inserts, image files, packaging Bills of Material and Packaging procedures based on instructions from Regulatory, Brand, Product Development and Packaging Development. Assists in all activities necessary to generate, revise, and assure the integrity of product labels and package inserts, domestic and foreign, for all products manufactured at Zimmer or products manufactured for Zimmer at External Alliance sites. Reviews labels and package inserts in the labeling and package inserts systems to confirm information is accurate
Principal Duties and Responsibilities
Revises and updates all ZWI's related to label design, revision and approval.
Creates labels for all new projects and revises for all existing products.
Assists with labeling efforts with other Zimmer sites when necessary.
Assists with the revisions of all Warsaw control package inserts at all Warsaw sites, other Zimmer sites, External Alliance Partners and suppliers.
Works with Development, Brand and Marketing functions globally to achieve and ensure use of a global Zimmer label format.
Creates digital files used in Zimmer labeling.
Creates packaging material specifications.
Expected Areas of Competence
Strong organizational and analytical skills are required. Must also have strong attention to detail.
Clear and concise oral and written communication skills are required.
Must have demonstrated ability to handle stress and quickly analyze problems in a professional and courteous manner.
Should have knowledge of U.S. and international government regulations regarding labeling requirements for medical devices and general regulatory knowledge;
Should have working knowledge of Zimmer orthopaedic implants and instruments;
Must be detail oriented with excellent organizational skills, excellent communication skills; ability to make informed decisions; and ability to work well with others.
Computer skills, including word processing and ability to use various databases, is required.
Education/Experience Requirements
An Associates degree preferred; or two years of equivalent on the job training/experience is required.
Travel Requirements
Up to 10%
Additional Information
EOE M/W/Vet/Disability

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