Senior Regulatory Labeling Specialist

Integra LifeSciences • Princeton, FL

21h

About The Position

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 Senior Regulatory Labeling Specialist – Enterprise Labeling has overall accountability to collaborate with cross functional teams to ensure compliance with the creation and relevant updates of labeling. Review and approval of new and existing labeling and design concepts ensuring that content follows regulatory labeling requirements and guidelines, and that the label content and design are correct. Find opportunities to improve product labeling clarity, appearance, consistency and reduce product labeling cost. Support all Codman Surgical Specialties and Tissue Technologies product lines within the Integra LifeSciences product portfolio manufactured by Integra and our external manufacturing partners (CMOs) by leading the development and execution of labeling for new and existing products and ensuring delivery of all agreed timelines. Identify and implement labeling process improvements, new policies, and procedures, and establish best practices. Develop relationships with strategic external partners (i.e., CMOs) in support of Integra’s expanding commercial portfolio and manage ongoing relationships. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Lead the 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 and cross functional partners on labeling best practice. Partner with labeling project leaders and project teams to ensure label branding, regulatory contents, and layout are consistent across all product lines. Help drive the global implementation of the electronic label artwork management system to legacy Integra sites and all new acquisitions. Collaborate closely with partners in manufacturing to keep the label printing process functioning on a day-to-day basis, resolving production issues to ensure label printing availability. Help train label design associates and label print operators on labeling processes. Work closely with IS partners to support the health of the labeling system through troubleshooting and implementing process improvements through the IS change control process. Manage multiple projects while working in a complex cross functional environment. Our partnership with the manufacturing sites, CMO suppliers and print suppliers, is especially important to our success. You will need to build and maintain those relationships to ensure seamless execution of new and revised labeling. To maintain consistency and quality in our labeling, you will ensure global coordination of labeling graphics including standardization of designs (i.e., Global Branding) for worldwide use and support localization strategies with creative solutions. You will support development and use of current and new tools, technologies, and processes to support efficient global labeling development and worldwide submissions and approvals. Interact and coordinate activities with other departments, external vendors, and customers. Influences and collaborates across stakeholder groups in the areas of labeling process / continuous improvements, identify and implement opportunities. Offer general guidance or training staff. Performs all other related duties as directed by manager.

Requirements

• Bachelor’s degree in Packaging Science, Graphic Design or related field needed.
• 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 including Word, PowerPoint, and Excel
• In-depth knowledge of U.S. and International regulations and guidelines pertaining to labeling and proven ability to decipher and understand implications of label changes on pending and approved labels.
• Demonstrated knowledge of FDA regulations, ISO 13485, Medical Device Directive Regulation (93/42EEC), and other US and international regulations and standards.
• Demonstrated organizational, management and communication skills.
• Ability to travel up to 30% or more if needed based on site needs.
• Understanding of pharmaceutical or medical device packaging, user documents, and content requirements are necessary.
• Excellent attention-to-detail.
• Advanced project management skills.
• Ability to acknowledge issues or problems and work quickly to find solutions.

Nice To Haves

• Knowledge of Adobe Creative Suite software including InDesign, Photoshop, and Illustrator a plus
• Familiarity with ERP and Digital Workflow/Artwork Management systems.
• Experience in product lifecycle management systems preferred.

Responsibilities

• Lead the 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 and cross functional partners on labeling best practice.
• Partner with labeling project leaders and project teams to ensure label branding, regulatory contents, and layout are consistent across all product lines.
• Help drive the global implementation of the electronic label artwork management system to legacy Integra sites and all new acquisitions.
• Collaborate closely with partners in manufacturing to keep the label printing process functioning on a day-to-day basis, resolving production issues to ensure label printing availability.
• Help train label design associates and label print operators on labeling processes.
• Work closely with IS partners to support the health of the labeling system through troubleshooting and implementing process improvements through the IS change control process.
• Manage multiple projects while working in a complex cross functional environment.
• Ensure global coordination of labeling graphics including standardization of designs (i.e., Global Branding) for worldwide use and support localization strategies with creative solutions.
• Support development and use of current and new tools, technologies, and processes to support efficient global labeling development and worldwide submissions and approvals.
• Interact and coordinate activities with other departments, external vendors, and customers.
• Influences and collaborates across stakeholder groups in the areas of labeling process / continuous improvements, identify and implement opportunities.
• Offer general guidance or training staff.
• Performs all other related duties as directed by manager.

Benefits

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level