Sr. Regulatory Labeling Design Project Specialist

Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Sr. Regulatory Labeling Design Project Specialist manages labeling projects from beginning design stages through to final production. Project leader for labeling related projects including project management in addition to creating, reviewing, approving, and maintaining finished goods labeling artwork and templates for packaging and user documents. This role requires an understanding of print production processes to effectively aid in the execution of end-to-end label implementation. You will manage the execution and implementation of medical device labeling, ensuring compliance with both internal corporate standards and external regulatory requirements. This role will be managing the strategic and tactical labeling projects from the business to meet quality standards, timelines, company goals, regulatory compliance, and cost management/process efficiency goals. The Sr. Regulatory Labeling Design Project Specialist will collaborate with cross-functional teams, including Marketing, Regulatory, Quality Assurance, R&D, and Global Operations, to define project requirements, artwork specifications, and verify content. Additionally, the role involves developing, reviewing, approving, and executing label development strategies and timelines to support new product launches and updates. Functional understanding of regional regulatory requirements is essential, ensuring compliance with FDA, MDR, ISO, and other global regulations.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Complete project management, with minimal supervision, of labeling projects received from project assignment through component release.
• Responsible for graphic development and artwork submission through the digital workflow. Coordinate the execution of product labeling artwork using Integra’s validated artwork management system (Kallik)
• Obtain translations and manage the localization process.
• Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across assigned projects and sites.                       
• Aid in integrating and implementing Integra’s electronic labeling artwork management system across manufacturing sites.

• Coordinate and support labeling production implementation processes with manufacturing sites and suppliers.
• Responsible for troubleshooting and resolving hardware and software errors in print production.

• Work with core product teams to develop labeling content for all levels/layers of labeling in multiple product families/portfolios.
• Maintain artwork files, including digital files and artwork archives.
• Manage artwork approval processes including approving artwork and proof approvals consistent with established standards.
• Proven ability to manage multiple projects/activities along with conducting and/or taking part in project meetings, as needed.
• Global coordination of packaging graphics including standardization of designs (Global Branding) for worldwide use.
• Consults with print production experts internally and externally, such as Engineering/Manufacturing for in-house printing, and external print suppliers.
• Compliance with FDA and international regulations, and an understanding of regulated documents and change control.
• Coordinate with other functional areas to process multiple requests, schedule priorities, and implement approved changes.
• Offer general guidance or training staff.
• Performs all other related duties as directed by manager.

Education: A bachelor’s degree or higher is preferred in Graphic Design, Packaging Science (Design), Printing or equivalent experience in production labeling required.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

Minimum of 5+years graphic/labeling development and print production experience required. Experience in Adobe Creative Cloud (Illustrator, Photoshop, InDesign, Acrobat), and Microsoft Office. Exp