Summary:

 The Labeling Work Stream Lead willbe responsible forworking with a cross-functional team to develop the labeling content,completethe labeling layout, and working with the manufacturing site as necessary to release new or revised labeling. The WSL willbe responsible fordeveloping timelines for the labeling work stream within New Product Development Projects.

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

The abilityto workquickly butalsoremainsextremely detail-oriented to produceaccurateandcompliantlabelingwill be key.The WSL will beable 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, andmaintainlabeling 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 forapprovalof labeling; complete labelingdesign; andensure 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.

• Troubleshootproblems as theyarise with the supplier/printer.

• Problem solves, thinks critically, and communicates with confidence.

• Work in a highly regulated environment.

MinimumRequired:

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 abilityrequired.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Bachelor’sdegree, coupled withanycourse work in graphic design, print production, visual arts

• 3+years ofworkexperience, displayingclear knowledge of print production and design

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

• Ability tomanagemultiple projects simultaneouslywhilemaintainingstrong analytical,verbal,and written communication skills. 

• Experience beingprocess-orientedanddemonstratesaself-startermindset

• Continuouslystaysup to date with new production techniques and trends through research and education.

Preferred Skills/Experience:

• ABachelor’s degree in Graphic design

• Experience working in regulated environments

• Hasa track recordofmanagingmultipleprojectsinpreviousroles

• Previousexperience andknowledge of the printing process

• Has aProduction Graphics background

• Previousexperiencewith designing the graphic aspect of product packaging forMedical Devices

• Bilingualin English andSpanish