Job Posting for Global Labeling Specialist - Urgent Need at MillenniumSoft Inc

Position : Global Labeling Specialist

Location : Warwick, RI

Duration : 12 Months

Total Hours/week : 40.00

Client: Medical Device Company

Job Category: Research & Development

Level Of Experience: Mid-Level

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

Job Description

The Global Labeling Specialist works within Research and Development and will be required to interface with all areas of compliance and manufacturing along with finance and marketing as needed.
The specialist will be responsible for labeling within BDI Surgery, both new and sustaining products.
Labeling includes project management, design and development, approval, and the implementation at all manufacturing sites or electronic publication of product labeling.
The labeling function works closely with Regulatory Affairs to ensure compliance with domestic and international regulations during label development.
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.
Design’s 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 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.

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Salary.com Estimation for Global Labeling Specialist - Urgent Need in Warwick, RI

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