Job Title: Senior Label Designer
Pay rate: $85- $96 per hour
Duration: 12 months (will be extended after a year)
W2 contract only (No C2C)
Location- Portage, MI, 49002 (Hybrid)
Who We Want
- Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
- Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What You Will Do
The Senior Label Designer will collaborate with product SMEs to assess and gather content and is responsible for execution of label format and content compilation using specialized software. This role partners with hospital and healthcare facility staff in global markets. Labels must be compliant with regulations, standards, and business requirements therefore attention to detail is essential and a high caliber of collaboration skills and customer focus is needed.
Additional responsibilities of the role include:
- 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.
- Learns and owns the supplemental labeling process.
- Communicate impact of language translation for alignment with project timelines and cost
- Initiate/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 Need
Required:
- Bachelor's degree (B.S.) in related field or equivalent.
- Atelast 2+ years of related experience.
Preferred:
- Previous work experience within a regulated industry
- Able to apply fundamental and advanced concepts, practices, and procedures related to labels
- Experience with a rigorous quality change management process
*** If this position may be interested to you, please email me back at ...@kellyservices.com with your most up to date resume in word format) and advise the best time and number at which you can be reached****