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Labeling Specialist in Naples, FL ,  at Arthrex

Date Posted: 1/25/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Naples, FL
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    1/25/2019

Job Description


Requisition ID:
41701
Title:
Labeling Specialist
Division:
Arthrex, Inc.
Location:
Naples, Florida

Main Objective:

Primary responsibility is to Implement and maintain global labeling database and label formats; plan, coordinate, create and determine size arrangements of illustrative material and copy for labeling; support internal and externally contracted manufacturing with label printing system knowledge serving the global labeling database and print stations.  A significant additional responsibility for Labeling Specialists is to manage, verify and maintain product data in shared global product databases.

Essential Duties and Responsibilities:

  1. Using multiple label design software platforms, coordinate information to populate labeling database and label formats/templates and supported printing equipment internally and externally where labels for Arthrex products will be printed.
  2. Support Packaging Engineering and Regulatory Affairs to develop labeling in compliance to company standards, FDA requirements and the ISO Directive, planning and coordinating activities to support development and production needs.
  3. Prepare, coordinate and review documentation required for new/revised labeling; may also include management of translation activities at a future date.  Develop Engineering Change Order (ECO) records and associayed documentation to support Engineering activities.
  4. This position will also serve as a contact for trouble-shooting system problems, working with software subcontractors to maintain operation of the software, and for equipment solutions when they arise.

Education/Experience

  • Bachelor’s Degree Required
  • Minimum 2 years’ experience in medical device labeling.
  • Proficiency in the use of Agile PLM and SAP ERP systems highly desirable.
  • Proficiency in Adobe Illustrator and limited working knowledge of CAD or AutoCad software would be beneficial.

Knowledge/Skills

  • Capability in designing labels in multiple software environments.  Including but not limited to Loftware and Innovatum/ROBAR.
  • Basic knowledge in the creation of product graphics using Adobe Illustrator, Photoshop, AutoCAD and other product graphic applications.
  • Assist in the support of Packaging Engineering and Regulatory Affairs to develop labeling in compliance to company standards, FDA requirements and the ISO Directive, planning and coordinating activities to support development and production needs.
  • Generate Change Request documentation to support Engineering activities.
  • Effective written and verbal communication skills.
  • Assist in the generation of work procedures related to label development.
  • Manage the data collection and publishing of shared product data to the FDA’s GUDID, and future international equivalents to the GUDID via the Product Information Management (PIM) system or future alternative means.
  • Knowledge of MS Office required.

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.