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 whats 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 endtoend 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 crossfunctional 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 dutysatisfactorily.

• 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 Integras 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 Integras 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 inhouse 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 bachelors 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 5years graphic/labeling development and print production experience required. Experience in Adobe Creative Cloud (Illustrator Photoshop InDesign Acrobat) and Microsoft Office. Experience in file development and workflow for multiple enduses including print. Understanding of pharmaceutical or medical device packaging user documents labeling regulations and content requirement is necessary. Excellent attention to detail and organizational skills. Advanced project management skills. Ability to acknowledge issues or problems and work quickly to find solutions. Demonstrate proficient writing and communication skills. Experience with change management. Experience with Plant support as it relates to documentation and spec changes that affect labeling and print changes.

Special Skills: Must be proficient in Illustrator and InDesign. Experience with Data Matrix codes and UDI labeling. Must be initiativetaker and can work independently with minimal supervision. Proven ability to manage multiple projects/activities. Must be able to manage quick turnarounds while keeping high quality in a demanding environment. Aptitude for learning new software and systems. Experience and/or knowledge of digital asset management/digital workflow and XML a plus.

Specialized Training: Familiarity with ERP and Digital Workflow/Artwork Management systems. Experience in production lifecycle management systems preferred.

Integra LifeSciences is an equal opportunity employer and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race marital status color religion sex age national origin sexual orientation physical or mental disability or protected veteran status.

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