Job Description

• Location : Portage, Michigan (49002)
• Duration: 6 month assignment (Contract extension potential)
• Type: W2 contract (NO C2C OR THIRD PARTY)
• Pay: Negotiable depending on direct-related experience
• Work Authorization : Must be currently in the United States with active employment authorization documents without current sponsorship.

Summary:

In this role you will collaborate with product SMEs to assess and determine label requirements and content: Regulatory Affairs, Product Development, Product Safety Engineering, Packaging Engineers, Clinical Sciences, Marketing, Trade Compliance, etc.

• Under minimal supervision, develops and maintains labels for medical devices.
• Collaborates with product subject matter experts to gather and assess labeling content.
• Executes label format and compiles content using specialized software.
• Audience for labels includes hospital and healthcare staff in global markets.
• Labels must comply with medical device regulations, standards, and business requirements.

Key Responsibilities

• Participate in new product label planning meetings and capture requirements using quality system planning documents.
• Design label formats for functional usability by healthcare staff
• Use specialized labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system
• Ensure barcodes pass verification testing
• Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers
• Support multiple concurrent labeling projects for new products and label maintenance
• Contact external suppliers to resolve label output details.
• Manage labels in PLM/CMS system for controlled label releases and revision management.
• Manage work to meet project milestones.
• Inform project managers of relevant aspects of language translation and impact to label design.
• Communicate impact of language translation for alignment with project timelines and cost
• Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements

Important information: To be immediately considered, please send an updated version of your resume to [email protected].

*** (Kelly does not expense relocation/interview costs)**

• Work Authorization: Must be currently in and able to work in the United States with current employment authorization documents without current sponsorship.

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