Labeling Work Stream Lead

About This Role

Lead the product labeling workstream from initiation to implementation for medical devices, ensuring compliance with global regulatory requirements. This role requires a blend of project management skills and advanced understanding of label design.

Responsibilities

• Demonstrate 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 cross-functional project team members from Marketing, Regulatory, R&D, Packaging, Quality Assurance, and Operations
• Facilitate redlining and content development for labeling
• Manage the labeling process for approvals and complete labeling design
• 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
• Troubleshoot problems as they arise with the supplier/printer
• Problem solve, think critically, and communicate with confidence
• Work in a highly regulated environment

Requirements

• Intermediate project management skills
• Advanced understanding of label design
• Ability to produce accurate and compliant labeling
• Strong typographic and layout skills with strict attention to detail
• Outstanding organizational, project management, and file-organization skills
• Strong communication skills
• Solid knowledge of the printing process
• Adept with software applications such as the Adobe Creative Suite and Microsoft Office Suite (including Microsoft Project and Microsoft Teams)
• Strong analytical skills
• Ability to handle multiple projects simultaneously
• Process-oriented self-starter
• Ability to stay up to date with new production techniques and trends
• Knowledge of global regulatory requirements such as CFR 801 (US) Medical Device Labeling, ISO 15223 Medical Device Symbols, and EU-MDR (Medical Device Regulations)

Qualifications

• Bachelor’s degree, preferably in Graphic design or related field
• 3 or more years of experience in print production or graphic design

Nice to Have

• Excellent oral and written communication skills with abilities in Spanish
• Production Graphics background
• Medical Device experience

Skills

* Required skills