**CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY**
Labeling Specifications Specialist (24 month contract // Minneapolis, MN):
Hybrid in office 3 days per week
Top Skills:
Working knowledge of the Microsoft Office suite and skills with Adobe CS3 (or later) publishing suite of softwareIdeally Adobe Illustrator experienceExperience with Medical Package labelingExperience releasing specs/drawings in a PLM system (Enovia/Windchill)High degree of accuracy and strong proofing skills and attention to detailSolid communication and ability to work independentlyA Day in the Life:
In the exciting role of Labeling Specialist, you will have responsibility and authority design and format all labeling for new and existing products under the direction of the Spine and Biologics Labeling department, while adhering to regulatory guidelines and the Corporate Brand Strategy for packaging and labeling. Additionally, you will be responsible for controlling and tracking labeling approval requests.
Duties:
- Creates, reviews, and reproduces content required for labeling medical products using professional graphic design or labeling software.
- 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.
- Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools, and/or policies.
Minimum Requirements
- Bachelors degree
- 2+ years of labeling experience required
- Basic understanding of package label requirements for medical device
- 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.
- This includes providing input and reviewing labeling, verification/validation testing, and other applicable design/manufacturing documentation.
- 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.
- Experience with PLM systems for routing design documentation (Enovia, Agile, Windchill)
- 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