Product Labeling Specialist

Mentor, OH

Posted: 12/04/2018 Employment Type: Temp to Hire Industry: Manufacturing Job Number: SEI002-08 Pay Rate: $23-$28/hr.

Our client in Mentor, OH, is a leading provider of infection prevention and other procedural products and services. They are searching for a Product Labeling Specialist to join their team.
The 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.

$23-$28/hr.
Part time, 20 hrs./week, within Mon-Fri, 8am-5pm

Responsibilities:

  • Demonstrates excellent understanding of company products and product labeling requirements, including branding, requirements and regulations, specifications, and language requirements.
  • Demonstrates thorough understanding of the company engineering and design change process.
  • Interfaces 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.
  • Coordinates 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.
  • Develops project supporting documentation as assigned, including scientific documentation, risk management documentation, and on-line matrix databases and documentation.
  • Coordinates with graphic designers, engineers, scientists to develop total instructional literature and product labeling projects.
  • Ensures 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.
  • Initiates and sets up project development and labeling review packets/folders using engineering drawings, design files, visual references, and research.
  • Assists in formulating packing specifications (paper, packaging, printing specifications, inks) in conjunction with engineering, scientific, and manufacturing/operations.
  • Assists supervisor with project management activities, such as determining department and project priorities, resource allocation, and schedule planning.
  • Responsible for self-direction in scheduling workload and prioritizing projects for self and any subordinates.
  • Participates on project teams and establishes good working relationships within the Corporation.
  • Participates in refining current processes, troubleshooting problems and documenting processes, procedures and results.
  • Possesses excellent ability to observe detail, attention to consistency and standard practices regarding product labeling.
  • Coordinate with production on materials management, MRP (stocking, usage, inventory, purchasing).
  • Prepares and conducts cross-functional technical reviews required for the development of medical device product labeling, packaging, or processes.
  • Uses labeling designer software to assist graphic design team to make edits, layout documents, place graphics.
  • Familiar with regulations for technical writing/medical device labeling (FDA, CDRH, ISO, BSI, etc.)
  • Coordinates translation projects, submissions.
  • Responsible for developing and maintaining risk management documentation as assigned.
  • Responsible for maintaining company web-based Customer-databases/matrices, application tools and related documentation.
  • Controls assigned engineering change requests and notices, creation and assignment of tasks and related activities.
  • Write and illustrate instructional and informational copy

Education Requirements

  • Minimum of Bachelor’s degree in English, communications, or in technical field, with strong secondary emphasis on language skills or equivalent experience required. Degree in technical writing or demonstrated comparable proficiency highly desirable.
  • Three years of experience in writing technical documents with an emphasis on medical device operator manuals and instructional literature required.
  • Minimum five years of experience with electronic desktop publishing equipment and layout programs, Adobe Creative Suite preferred.

Technical Requirements

  • Requires 5 years of product labeling experience; such as color specifications, logo, branding, trademark usage, UDI, GHS, regulatory, DOT, market requirements, shipping regulations.
  • Requires 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).
  • Requires 5 years of experience working with outside print vendors.
  • Coordinate with production on materials management, MRP (stocking, usage, inventory, purchasing).
  • Prepares and conducts cross-functional technical reviews required for the development of medical device product labeling, packaging, or processes.
  • Familiar with regulations for technical writing/medical device labeling (FDA, CDRH, ISO, BSI, etc.)
  • Coordinates translation projects, submissions.
  • Proficient on company brands and branding schemes.
  • Proficient on company policies and procedures, quality systems procedures, regulatory guidelines and practices.
  • Responsible for maintaining company web-based Customer-databases/matrices, application tools and related documentation.
  • Controls assigned engineering change requests and notices, creation and assignment of tasks and related activities.

Allison Leone

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