Labeling Stream Lead; Hybrid​/Covington, GA

Job Description Summary

Job Description

We are the makers of possible

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

A successful applicant for the Product Labeling Work Stream Lead (WSL) position must possess a mix of intermediate project management skills and advanced understanding of label design along with some creativity. Must have time management skills to oversee the creation, release, and the implementation of Instructions for Use (IFU) [aka DFU], package labels, translations, and other relevant labeling components/processes. Must be able to work quickly, but also remain extremely detail-oriented and able to produce ACCURATE and COMPLIANT labeling.

The Labeling Work Stream Lead must be able to work with cross-functional teams. Able to develop, design, and release medical device product labeling with the support of cross-functional business units that comply with global regulatory requirements such as CFR 801 (US) Medical Device Labeling, ISO 15223 Medical Device Symbols, and EU-MDR (Medical Device Regulations).

The Labeling Work Stream Lead will be responsible for working with a cross-functional team to develop the labeling content, completing the labeling layout, and work with the manufacturing site as necessary to release new or revised labeling. The WSL will be responsible for developing timelines for the labeling work stream within a New Product Development Project or large Sustaining Engineering Project.

Strong typographic and layout skills with strict attention to detail. Outstanding organizational, project management, and file-organization skills are a must. Strong communication skills and able to lead and own the labeling workstream for New Product Development projects and/or sustaining labeling projects.

• Demonstrates knowledge of, and the ability to apply, labeling procedures and processes.
• Accountable for the execution of specific tasks with limited oversight from supervisor.
• Create, manage, and maintain labeling project schedules.
• Lead the product labeling workstream from initiation to implementation.
• Collaborate closely with the project manager and project team members from Marketing, Regulatory, R&D, Packaging, Quality Assurance, and Operations.
• Facilitate redlining and the development of content for labeling; manage the labeling process for approvals of labeling; complete labeling design; and ensure implementation of labeling at the manufacturing site.
• Create PDFs, zip files for print and client review and prepare images for online applications (e.g., e-labeling).
• Prepare final source files based on supplier specifications for several types of printing, including various formats of production-ready artwork.
• Troubleshoot problems as they arise with the supplier/printer.
• Problem solves, thinks critically, and communicates with confidence.
• Work in a highly regulated environment.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• A Bachelor’s degree required, preferably in Graphic design or related field.
• 3 or more years of experience in print production or graphic design.
• Significant course work in graphic design, print production, visual arts or a related field, along with an outstanding portfolio and work experience that demonstrates clear knowledge of print production and design.
• The applicant having a…