Labeling Coordinator Jobs

Department: Regulatory

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Senior Director Labeling Regulatory Compliance and Remediation

Description

The Labeling Coordinating Technician creates labels, package inserts, and image files based on instructions from Labeling Specialist, Regulatory Affairs, Marketing, Development, Packaging, Legal, etc. Assists in all activities necessary to create, revise, and assure the integrity of product labels and package inserts, domestic and foreign, for all Exactech products. Reviews labels and package inserts in the label system(s) to confirm accuracy. Submits labels and instructions for use for translations per local language requirements. Performs translation checks upon receipt. Communicates with print vendor regarding instructions for use print implementation and performs proof reviews. May perform eLabeling website loads and UDI data loads for U.S. and foreign regulatory bodies. The position requires working knowledge of the labeling system(s) as well as an understanding of the IFU process and implementation steps. Works effectively, efficiently, and productively to ensure timely creation/revision of product labels and instructions for use within the Exactech labeling systems. Strong attention to detail, written and oral communication, teamwork, and organizational skills are essential, as well as an understanding of Exactech products and their use.

Key Responsibilities

• Works with external translation supplier to obtain label and instruction for use translations. Performs quality checks as appropriate.
• May perform eLabeling website loads.
• 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 Packaging to identify specifications for the printed IFU necessary for print vendor.
• Creates digital files for Exactech label as needed.
• Assists with the creation, revision, implementation of instructions for use and works with external partners and suppliers for implementation.
• Works with print vendor to obtain printer proof of instructions for use. Reviews and approves for accuracy and further implementation.
• Initiate change requests for new and revised labeling, work with Labeling Specialist to create, maintain, and implement compliant labeling.
• 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.
• Able to work within the QMS to route applicable quality documentation for change control, CAPA, NC, etc pertaining to labeling issues
• Creates labels for all new projects and revises for all existing products.
• Identify potential roadblocks, provide proposed solutions, and escalate to supervisor.

Skills, Knowledge & Expertise

Minimum Required Qualifications:

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

Preferred Qualifications

• Strict attention to detail
• Develops solutions to a variety of problems of basic scope and complexity
• Ability to follow established grammatical and formatting conventions, templates and style guides
• 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
• Basic problem-solving, organizational, analytical and critical thinking skills
• Ability to build stable working relationships internally
• Excellent written and verbal communication skills and interpersonal relationship skills
• Previous experience working in a medical FDA regulated industry
• Excellent computer skills including usage of MS Office Suite