12 month contract with full Stryker benefits.
What you will do:
Responsibilities
As a member of the Technical Publications team, create and revise product labels to meet labeling requirements for medical devices.
Collaborates with product subject matter experts to gather and assess labeling content.
Executes label format and compiles content using specialized software
This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
The job requires attention to detail in making evaluative judgements based on the analysis of factual information
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.
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
Use desktop publishing software to design labels produced by external suppliers
Ensure barcodes pass verification testing
Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers
As needed, support label translation strategies that satisfy international labeling needs
Support multiple concurrent labeling projects for new products, mergers and acquisitions, and label maintenance
Review labels for completeness and presentation including labels created by others
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
Initiate, drive and assist with departmental continuous improvement endeavors
Collect and track data/metrics associated with projects
Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements
May assist with regulatory audits
What you will need:
Bachelors Degree in Communications, Data Management, Procurement, General Business Management, Regulatory Sciences, or equivalent is required.
(Level 8)
Experience working with/entering data into data-driven software
Preferred experience navigating challenges related to language translation and Excel
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