Regulatory Labeling Specialist

Integra LifeSciences•Princeton, NJ

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 Regulatory Labeling Specialist 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 complies with regulatory labeling requirements and guidelines, and that the label content and design are correct. Finding 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. Identifying and implementing labeling process improvements, new policies, and procedures, and establishing best practices. Develop relationships with strategic external partners (i.e., CMOs) in support of Integra’s expanding commercial portfolio and manage ongoing relationships. Project Manager for medium to large scale projects (i.e., Acquisitions, New Product Introductions, etc.) Lead and coordinate 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. Assist with implementing global electronic label artwork management system to both legacy Integra sites as well as all new acquisitions. Manage multiple projects while working in a complex cross functional environment. 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. Performs all other related duties as directed by manager.

Requirements

Bachelor’s degree in Packaging Science, Graphic Design or related field required.
Minimum of 3 -5 years of packaging/labeling development or graphic design experience; including experience in a regulated pharmaceutical or medical device industry.
Excellent organizational skills
Aptitude for learning new software and systems.
Basic project management skills
Ability to find 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.

Nice To Haves

Knowledge of Adobe Creative Suite software including InDesign, Photoshop, and Illustrator a plus

Responsibilities

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 complies with regulatory labeling requirements and guidelines, and that the label content and design are correct.
Finding 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.
Identifying and implementing labeling process improvements, new policies, and procedures, and establishing best practices.
Develop relationships with strategic external partners (i.e., CMOs) in support of Integra’s expanding commercial portfolio and manage ongoing relationships.
Project Manager for medium to large scale projects (i.e., Acquisitions, New Product Introductions, etc.)
Lead and coordinate 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.
Assist with implementing global electronic label artwork management system to both legacy Integra sites as well as all new acquisitions.
Manage multiple projects while working in a complex cross functional environment.
Support development and use of current and new tools, technologies, and processes to support efficient global labeling development and worldwide submissions and approvals.
Performs all other related duties as directed by manager.