Senior Regulatory Labeling Specialist
Integra LifeSciences Corporation, Princeton, New Jersey, us, 08543
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, colleagues challenge what’s possible and advance patient outcomes through innovative treatment pathways.
Senior Regulatory Labeling Specialist – Enterprise Labeling Overall accountability to collaborate with cross‑functional teams to ensure compliance with the creation and relevant updates of labeling.
Responsibilities
Review and approve new and existing labeling and design concepts to ensure they meet regulatory labeling requirements and guidelines.
Identify opportunities to improve product labeling clarity, appearance, consistency, and reduce cost.
Support all Codman Surgical Specialties and Tissue Technologies product lines across the Integra LifeSciences portfolio, leading labeling development and execution for new and existing products and ensuring delivery on agreed timelines.
Identify and implement labeling process improvements, new policies, and procedures, and establish best practices.
Develop relationships with strategic external partners (e.g., CMOs) and manage ongoing collaborations.
Lead design, development, approval, and implementation of new or revised product labeling.
Coordinate packaging artwork development and changes with product marketing and manufacturing teams.
Serve as label content and execution subject‑matter expert; advise project teams on labeling best practice.
Partner with labeling project leaders to ensure label branding, regulatory content, and layout consistency across all product lines.
Drive global implementation of the electronic label artwork management system to legacy Integra sites and new acquisitions.
Collaborate closely with manufacturing partners to keep the label printing process functioning, resolving production issues to ensure label availability.
Help train label design associates and label print operators on labeling processes.
Work with IS partners to support the health of the labeling system through troubleshooting and the IS change‑control process.
Manage multiple projects within a complex cross‑functional environment.
Build and maintain relationships with manufacturing sites, CMO suppliers, and print suppliers to ensure seamless execution of new and revised labeling.
Ensure global coordination of labeling graphics, standardization of designs (Global Branding), and support localization strategies.
Advance development and use of current and new tools, technologies, and processes to support efficient global labeling development and worldwide submissions and approvals.
Coordinate activities with other departments, external vendors, and customers, influencing and collaborating on labeling process and continuous improvement opportunities.
Offer general guidance or training to staff.
Perform all other related duties as directed by the manager.
Qualifications
Bachelor’s degree in Packaging Science, Graphic Design or related field.
Minimum of 5–7 years of packaging/labeling development or graphic design experience, including experience in a regulated pharmaceutical or medical device industry.
Experience with enterprise labeling (on‑demand) systems.
Excellent organizational skills.
Aptitude for learning new software and systems.
Strong project‑management skills.
Ability to identify issues or problems and work quickly to find and implement solutions.
Knowledge of core Microsoft Office software (Word, PowerPoint, Excel).
Knowledge of Adobe Creative Suite (InDesign, Photoshop, Illustrator) a plus.
In‑depth knowledge of U.S. and international labeling regulations and guidelines, and ability to interpret implications of label changes on pending and approved labels.
Knowledge of FDA regulations, ISO 13485, Medical Device Directive Regulation (93/42EEC), and other U.S. and international standards.
Demonstrated organizational, management, and communication skills.
Ability to travel up to 30% as needed.
Special Skills Understanding of pharmaceutical or medical device packaging, user documents, and content requirements. Excellent attention‑to‑detail. Advanced project‑management skills. Ability to acknowledge issues or problems and work quickly to find solutions.
Specialized Training Familiarity with ERP and Digital Workflow/Artwork Management systems. Experience with product lifecycle management systems preferred.
Salary Pay Range USD 81,650.00 – 112,700.00 per year. Salary ranges are determined by role, level, and location. Employees may also be eligible for bonus, commission, equity, or other variable compensation.
Benefits Employees and eligible dependents may participate in company‑sponsored benefit programs, including medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a 401(k) savings plan.
Equal Employment Opportunity 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. This site is governed solely by applicable U.S. laws and governmental regulations. For accommodations related to disability, please email careers@integralife.com.
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Senior Regulatory Labeling Specialist – Enterprise Labeling Overall accountability to collaborate with cross‑functional teams to ensure compliance with the creation and relevant updates of labeling.
Responsibilities
Review and approve new and existing labeling and design concepts to ensure they meet regulatory labeling requirements and guidelines.
Identify opportunities to improve product labeling clarity, appearance, consistency, and reduce cost.
Support all Codman Surgical Specialties and Tissue Technologies product lines across the Integra LifeSciences portfolio, leading labeling development and execution for new and existing products and ensuring delivery on agreed timelines.
Identify and implement labeling process improvements, new policies, and procedures, and establish best practices.
Develop relationships with strategic external partners (e.g., CMOs) and manage ongoing collaborations.
Lead design, development, approval, and implementation of new or revised product labeling.
Coordinate packaging artwork development and changes with product marketing and manufacturing teams.
Serve as label content and execution subject‑matter expert; advise project teams on labeling best practice.
Partner with labeling project leaders to ensure label branding, regulatory content, and layout consistency across all product lines.
Drive global implementation of the electronic label artwork management system to legacy Integra sites and new acquisitions.
Collaborate closely with manufacturing partners to keep the label printing process functioning, resolving production issues to ensure label availability.
Help train label design associates and label print operators on labeling processes.
Work with IS partners to support the health of the labeling system through troubleshooting and the IS change‑control process.
Manage multiple projects within a complex cross‑functional environment.
Build and maintain relationships with manufacturing sites, CMO suppliers, and print suppliers to ensure seamless execution of new and revised labeling.
Ensure global coordination of labeling graphics, standardization of designs (Global Branding), and support localization strategies.
Advance development and use of current and new tools, technologies, and processes to support efficient global labeling development and worldwide submissions and approvals.
Coordinate activities with other departments, external vendors, and customers, influencing and collaborating on labeling process and continuous improvement opportunities.
Offer general guidance or training to staff.
Perform all other related duties as directed by the manager.
Qualifications
Bachelor’s degree in Packaging Science, Graphic Design or related field.
Minimum of 5–7 years of packaging/labeling development or graphic design experience, including experience in a regulated pharmaceutical or medical device industry.
Experience with enterprise labeling (on‑demand) systems.
Excellent organizational skills.
Aptitude for learning new software and systems.
Strong project‑management skills.
Ability to identify issues or problems and work quickly to find and implement solutions.
Knowledge of core Microsoft Office software (Word, PowerPoint, Excel).
Knowledge of Adobe Creative Suite (InDesign, Photoshop, Illustrator) a plus.
In‑depth knowledge of U.S. and international labeling regulations and guidelines, and ability to interpret implications of label changes on pending and approved labels.
Knowledge of FDA regulations, ISO 13485, Medical Device Directive Regulation (93/42EEC), and other U.S. and international standards.
Demonstrated organizational, management, and communication skills.
Ability to travel up to 30% as needed.
Special Skills Understanding of pharmaceutical or medical device packaging, user documents, and content requirements. Excellent attention‑to‑detail. Advanced project‑management skills. Ability to acknowledge issues or problems and work quickly to find solutions.
Specialized Training Familiarity with ERP and Digital Workflow/Artwork Management systems. Experience with product lifecycle management systems preferred.
Salary Pay Range USD 81,650.00 – 112,700.00 per year. Salary ranges are determined by role, level, and location. Employees may also be eligible for bonus, commission, equity, or other variable compensation.
Benefits Employees and eligible dependents may participate in company‑sponsored benefit programs, including medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and a 401(k) savings plan.
Equal Employment Opportunity 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. This site is governed solely by applicable U.S. laws and governmental regulations. For accommodations related to disability, please email careers@integralife.com.
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