Product Labeling Specialist

Required

• Bachelor's Degree.
• Plus 3+ years of experience in writing or reviewing technical documents with an emphasis on medical device operator manuals and instructional literature. 
  • OR High School Diploma/GED.
  • Plus 6+ years of experience in writing or reviewing technical documents with an emphasis on medical device operator manuals and instructional literature.
• 5+ years of experience with electronic desktop publishing equipment and layout programs.
• 5+ years of product labeling experience; such as color specifications, logo, branding, trademark usage, UDI, GHS, regulatory, DOT, market requirements, shipping regulations.
• 5+ years of experience with graphic design and product labeling coordination; such as IFUs, package inserts, package/machine labels, cases, cartons, user manual and guides (wall charts, pamphlets).
• 5+ years of experience working with outside print vendors.

What You'll do as a Product Labeling Specialist

1. 1The Product Labeling Specialist is a multi-faceted position encompassing the development and maintenance of medical device product labeling, informational and instructional literature, packaging, internal document control, change control, process control, and implementation of required regulations and guidelines.
2. 2Demonstrates excellent understanding of STERIS products and product labeling requirements, including branding, requirements and regulations, specifications, and language requirements.
3. 3Demonstrates thorough understanding of the STERIS engineering and design change process.
4. 4Interfaces with R&D scientists, engineers, engineering designers, graphics designers, supervisors, project team leaders, managers, marketing personnel, operations personnel, vendors, and others to gather information for new or revised product labeling.
5. 5Coordinates product labeling project tasks through creation, development, completion, and release to production via the engineering change process, determining the best combination of resources to complete projects on time.
6. 6Develops project supporting documentation as assigned, including scientific documentation, risk management documentation, and on-line matrix databases and documentation.
7. 7Coordinates with graphic designers, engineers, scientists to develop total instructional literature and product labeling projects.
8. 8Ensures and verifies accuracy and completeness of documentation produced, including proofreading, completing and maintaining design control/project documentation, obtaining necessary approvals, and releasing to operations for production.
9. 9Initiates and sets up project development and labeling review packets/folders using engineering drawings, design fi les, visual references, and research.
10. 10Assists in formulating packing specifications (paper, packaging, printing specifications, inks) in conjunction
    with engineering, scientific, and manufacturing/operations.
11. 11Assists supervisor with project management activities, such as determining department and project priorities, resource allocation, and schedule planning.
12. 12Responsible for self-direction in scheduling workload and prioritizing projects for self and any subordinates.
13. 13Participates on project teams and establishes good working relationships within STERIS Corporation.
14. 14Participates in refining current processes, troubleshooting problems and documenting processes, procedures and results.
15. 15Possesses excellent ability to observe detail, attention to consistency and standard practices regarding product labeling.
16. 16Works with little supervision.