Labeling Specialist

Labeling Specifications Specialist (24 month contract // Minneapolis, MN):

Candidate will be supporting Labeling/Technical Writing requirements and should be comfortable using word processing tools (i.e. Adobe CS 3, MS Office, etc.) and electronic document management systems (i.e. Agile, MasterControl, Veeva, Documentum, eMatrix, ETQ, Windchill, etc.).

Hybrid 3-4 days in office.

Required Skills:

1. Experience with Medical Package labeling
2. Experience releasing specs/drawings in a PLM system (Enovia/Windchill)
3. Adobe Illustrator experience

Education Required: Bachelors Degree

Years’ Experience Required: 2 years of Medical Packaging and Labeling experience

Duties:

• Creates, reviews, and reproduces text required for labeling medical products.
• Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements.
• Monitors changes in labeling regulations in the US and/or abroad.
• Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application.
• Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools and/or policies.

Minimum Requirements

• Bachelors degree
• 1 years of experience required
• Basic understanding of package label requirements for medical device
• Experience with PLM systems for routing design documentation (Enovia, Agile, Windchill)
• Interact with internal marketing, R&D, QA, and project managers to provide regulatory input and guidance on changes to currently marketed products and for new product development.
• Previous experience with the development of package labeling designs
• Working knowledge of the Microsoft Office suite
• Skills with Adobe CS3 (or later) publishing suite of software, including InDesign, Illustrator and Photoshop
• High degree of accuracy and strong proofing skills
• Problem-solving, organization, and prioritization skills

Preferred Requirements:

• Experience in the development of labeling for the medical device industry preferred.
• Bachelor's Degree in Graphic Arts or Packaging Engineering background preferred
• Ability to use computers and other graphic-arts related technology
• Ability to understand the Engineering Change Request (ECR) process using a document control system