Labeling Coordinator Jobs

Description

Key Responsibilities

• Coordinate services and collaborates effectively with vendors and suppliers of services (e.g., translation vendors, instructions for use) to ensure execution of high-quality deliverables.
• Initiate change requests for new and revised labeling, work with Labeling Specialist to create, maintain, and implement compliant labeling.
• Creates labels for all new projects and revises for all existing products.
• Works with Packaging to identify specifications for the printed IFU necessary for print vendor.
• Creates digital files for Exactech label as needed.
• Works with external translation supplier to obtain label and instruction for use translations. Performs quality checks as appropriate.
• Assists with the creation, revision, implementation of instructions for use and works with external partners and suppliers for implementation.
• May perform eLabeling website loads.
• Able to work within the QMS to route applicable quality documentation for change control, CAPA, NC, etc pertaining to labeling issues
• Determine labeling requirements for routine labeling change packages (e.g., MDRs, sustaining changes label/IFU content, CMS migration) by supporting business needs for existing labeling documentation (e.g., IFU, product labeling, operations manual) and prioritizing execution workflow.
• May perform UDI data loads for U.S. and foreign regulatory bodies.
• Works with print vendor to obtain printer proof of instructions for use. Reviews and approves for accuracy and further implementation.
• Identify potential roadblocks, provide proposed solutions, and escalate to supervisor.

Skills, Knowledge & Expertise

• Prior knowledge/experience to work with labeling systems (e.g. PRISYM)
• An Associates degree preferred; or two years of equivalent on the job training/experience is required or
• Bachelor's Degree with 1 year of related experience
• Understanding of medical device labeling requirements, regulations and industry standards
• Understanding of domestic and international labeling development and implementation

• Basic problem-solving, organizational, analytical and critical thinking skills
• Excellent written and verbal communication skills and interpersonal relationship skills
• Develops solutions to a variety of problems of basic scope and complexity
• Knowledgeable of PRISYM (LOFTWARE) Labeling System
• Perform work independently on sections of projects and/or lines of work and reviewed for accuracy and soundness
• Participates in arranging own activities in accomplishing objectives
• Ability to build stable working relationships internally
• Ability to follow established grammatical and formatting conventions, templates and style guides
• Strict attention to detail
• Excellent computer skills including usage of MS Office Suite
• Previous experience working in a medical FDA regulated industry

About Exactech