Position: Associate Global Labeling Specialist

Location: Warwick, RI

Duration: 12+ Months Contract

Total Hours/week: 40.00

Client: Medical Device Company

Job Category: Research & Development

Level Of Experience: Entry Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Description:

The Associate Global Labeling Specialist works within Research and Development and will be required to interface with Packaging Engineering, Product Engineering, Product Managers/Marketing, domestic and international Regulatory Affairs, Quality, Purchasing and Manufacturing and will be responsible for labeling management for BDI Surgery. Labeling management includes the design and development, approval, and implementation at all manufacturing sites of all product labeling on new and sustaining projects. The labeling function works closely with Regulatory Affairs to ensure compliance with domestic and international regulations. This role is also responsible for working with multiple suppliers for translation services, packaging suppliers for printed labeling components, and contract manufacturers.

Essential Duties, Position 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.
• 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 under direct supervision.
• 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, 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 or related discipline.
• 0-2+ years’ required 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 utilizing computer-aided design equipment and/or graphic tools such as, CAD, Adobe Illustrator/Photoshop/InDesign, and other related software.
• Experience with a label design software (i.e. EasyLabel, NiceLabel, or BarTender) is preferred
• 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 and the ability to work effectively with cross functional teams.
• 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.
• Strong project management skills