Summary: 

 The Labeling Work Stream Lead will be responsible for working with a cross-functional team to develop the labeling content, complete the labeling layout, and working 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 New Product Development Projects. 

The WSL must have time management skills to oversee the creation, release, and implementation of Instructions for Use (IFU) [aka DFU], package labels, translations, and other relevant labeling components/processes.  

The ability to work quickly but also remains extremely detail-oriented to produce accurate and compliant labeling will be key. The WSL will be 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).  

Responsibilities: 

• 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 approval 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. 

Minimum Required: 

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. 

• Bachelor’s degree, coupled with any course work in graphic design, print production, visual arts 

• 3+ years of work experience, displaying clear knowledge of print production and design 

• Experienced with software applications (Adobe Creative Suite and Microsoft Office Suite including Microsoft Project and Microsoft Teams) 

• Ability to manage multiple projects simultaneously while maintaining strong analytical, verbal, and written communication skills.  

• Experience being process-oriented and demonstrates a self-starter mindset 

• Continuously stays up to date with new production techniques and trends through research and education. 

Preferred Skills/Experience: 

• A Bachelor’s degree in Graphic design 

• Experience working in regulated environments  

• Has a track record of managing multiple projects in previous roles 

• Previous experience and knowledge of the printing process 

• Has a Production Graphics background 

• Previous experience with designing the graphic aspect of product packaging for Medical Devices  

• Bilingual in English and Spanish