Labeling Specialist

Job Description

The Global Labeling Specialist works within Research and Development and interfaces with compliance, manufacturing, finance, and marketing as needed. Responsibilities include developing and modifying product labels, managing labeling changes, and supporting cross-functional teams.

Essential Duties, Position Responsibilities

• Develops and modifies labeling for product labels, cartons graphics, implant cards, patient leaflets, inserts and other related material ensuring compliance with medical, legal, and regulatory requirements.
• Supports a cross-functional team in collecting labeling content and translating it into a functional label layout using labeling software and/or illustrating software.
• Works on both commercialized and new product development products for all associated labeling requirements under direct supervision.
• Develops and manages labeling changes within the approved document management system.
• Designs product labeling considering product identification, worldwide requirements, sales appeal, aesthetic quality, printing, and production techniques.
• Manages multiple concurrent deadlines and prioritizes work independently.
• Supports all company initiatives as identified by management and in support of the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements.
• Complies with FDA regulations, other regulatory requirements, Company Policies, Standard Operating Procedures (SOP), working instructions, and task assignments.
• Aids in the design and development of packaging prototypes and supports R&D builds with labeling.
• Participates in Voice of Customer (VOC) activities through collaboration with Key Opinion Leaders (KOL’s).
• Develops, maintains, and manages all packaging graphics and labeling utilizing electronic desktop publishing equipment.
• Performs other related duties and responsibilities, on occasion, as assigned.

Education and Experience

• Bachelor's degree in Art/Graphic Design preferred (Associates w/ 3+ years direct, design and layout, labeling experience will be considered).
• 1-3+ years’ experience with developing artwork and graphics for FDA regulated medical device or drug products and creation and management of design changes in an electronic environment.
• Experience with a label design software (i.e. EasyLabel, NiceLabel, or BarTender) is required.
• Experience utilizing computer-aided design equipment and graphic tools such as, Adobe Illustrator/Photoshop/InDesign, and other related software.
• Strong project management skills.
• Ability to communicate effectively with internal and external customers and team members effectively and timely.
• Customer-service orientated with demonstrated ability to build cross-functional relationships with internal and external personnel.
• Excellent organization, problem solving, and communication skills, along with the openness to raise questions and ideas.
• Technical writing, copy editing, and verbal communication skills.
• Flexibility to accommodate and manage changing priorities, deadlines, and project needs.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Advanced knowledge of the manufacturing processes and ability to work with manufacturing plants to drive labeling changes into production.