Regulatory Labeling 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 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. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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. Qualifications: Bachelor’s degree in STEM, 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 Knowledge of Adobe Creative Suite software including InDesign, Photoshop, and Illustrator a plus 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. Salary Pay Range: $62,000.00 - $85,000.00 USD Salary Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process. Additional Description for Pay Transparency: 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 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. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected]. Unsolicited Agency Submission Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails. 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