Graphic Labelling Specialist II

Job Description

Duties and Responsibilities:

• Develops and modifies labeling for product labels, cartons graphics, implant cards, patient leaflets, inserts and other related material ensuring that they meet all medical, legal, and regulatory requirements for medical devices and drugs following the established design format, labeling style guidelines and branding standards.
• Leads and/or supports a cross-functional team collecting labeling content and translating it into a functional label layout utilizing labeling software and/or illustrating software.
• Works on commercialized and new product development products for all associated labeling requirements.
• Develops and manages labeling changes within the approved document management system.
• Designs product labeling considering such factors as 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 the U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements including ISO, 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.

Education and Experience:

• Bachelor’s degree in Art/Graphic Design preferred (Associates and/or experience will be considered in place of degree).
• 1+ year experience working in a regulated industry with exposure to manufacturing (e.g., medical device or pharma).
• Experience with a label software (e.g., Easy Label, Nice Label, Bartender, or enLabel).
• Experience designing and maintaining clinical labeling or marketing materials for a regulated industry will be considered towards design experience.
• Experience utilizing design software and graphic tools such as Adobe Illustrator, Photoshop, InDesign, Adobe Pro, and other related software.
• Regulatory experience and/or labeling experience in the medical field is preferred to expedite training/ onboarding.

Knowledge & Abilities:

• Project will require detail oriented individual and strong graphic creation/professional level document creation background (Illustrator or InDesign preferred).
• Strong Microsoft office skills needed due to high volume of emails and WORD document usages/communications.
• Adobe Acrobat – PDF editing knowledge required for document redline/tracked changes.