Director RA, Global Labeling - Integra LifeSciences
Princeton, NJ
About the Job
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 Director, Global Regulatory Labeling is responsible for overseeing the prioritization, creation, review, approval, and maintenance of finished goods labeling artwork and templates. This role requires a solid understanding of global labeling requirements, a basic understanding of labeling platforms, and print production processes to effectively manage end-to-end label implementation. The role requires the ability to manage people and prioritize projects based on business priorities as well as a functional understanding of global UDI, EUDAMED, and other region and country-specific labeling requirements to ensure compliance with FDA, MDR, ISO, and other global regulations. This role will work collaboratively across the enterprise to identify project needs and will oversee a team of individuals who have both labeling expertise as well as labeling creation capability. This role will also develop the appropriate labeling team organizational structure to ensure business needs are met. This role will also work closely with the quality assurance (QA) and product development organizations to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as listed below:
+ Oversee the prioritization, development, revision and approval of product global labeling, serve as a strategic cross-functional partner working closely with the labeling specialists and managers, cross-functional project teams including quality and operations, as well as the regulatory operations team
+ Coach and develop direct reports creating a high-performance culture, proactively assesses performance of direct reports and helps guide in their continued development
+ Foster an environment of compliance and integrity by managing and adhering to all company policies and Legal and Regulatory guidelines
+ Prioritize and oversee the execution of product label artwork utilizing Integra's validated artwork management system (Kallik)
+ Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across assigned projects and sites
+ Implement training for labeling organization to ensure appropriate expertise and capabilities within the function.
+ Oversee and collaborate with other functions to integrate and implement Integra's electronic labeling artwork management system across manufacturing sites.
+ Coordinate and support labeling production implementation processes with manufacturing sites and vendors
+ Oversee and prioritize the execution of on-demand label print proofs, barcode grading/verification
QUALIFICATIONS
+ Bachelor's degree and 7+ years of experience in regulatory affairs, quality assurance and/or labeling including direct experience with creating and implementing labeling.
+ A minimum of 10 years directly managing teams or leading program or project management activities.
+ Advanced and proven record managing complex projects and people in a cross-functional environment
+ Excellent attention to detail and organizational skills
+ Experience in regulatory affairs and quality assurance and working knowledge of global regulatory labeling requirements in key markets/geographies.
+ Ability to multi-task and problem solve
+ Excellent writing and communication skills; ability to use advanced features of MS Word, Excel and PowerPoint
+ Strong understanding of product life cycle management requirements
+ Must be able to independently travel via car or airplane to domestic and international locations if needed. Expected travel commitment is 0-15%.
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 (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
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 Director, Global Regulatory Labeling is responsible for overseeing the prioritization, creation, review, approval, and maintenance of finished goods labeling artwork and templates. This role requires a solid understanding of global labeling requirements, a basic understanding of labeling platforms, and print production processes to effectively manage end-to-end label implementation. The role requires the ability to manage people and prioritize projects based on business priorities as well as a functional understanding of global UDI, EUDAMED, and other region and country-specific labeling requirements to ensure compliance with FDA, MDR, ISO, and other global regulations. This role will work collaboratively across the enterprise to identify project needs and will oversee a team of individuals who have both labeling expertise as well as labeling creation capability. This role will also develop the appropriate labeling team organizational structure to ensure business needs are met. This role will also work closely with the quality assurance (QA) and product development organizations to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily as listed below:
+ Oversee the prioritization, development, revision and approval of product global labeling, serve as a strategic cross-functional partner working closely with the labeling specialists and managers, cross-functional project teams including quality and operations, as well as the regulatory operations team
+ Coach and develop direct reports creating a high-performance culture, proactively assesses performance of direct reports and helps guide in their continued development
+ Foster an environment of compliance and integrity by managing and adhering to all company policies and Legal and Regulatory guidelines
+ Prioritize and oversee the execution of product label artwork utilizing Integra's validated artwork management system (Kallik)
+ Create and maintain labeling project tracking tools and dashboards to monitor all labeling change deliverables across assigned projects and sites
+ Implement training for labeling organization to ensure appropriate expertise and capabilities within the function.
+ Oversee and collaborate with other functions to integrate and implement Integra's electronic labeling artwork management system across manufacturing sites.
+ Coordinate and support labeling production implementation processes with manufacturing sites and vendors
+ Oversee and prioritize the execution of on-demand label print proofs, barcode grading/verification
QUALIFICATIONS
+ Bachelor's degree and 7+ years of experience in regulatory affairs, quality assurance and/or labeling including direct experience with creating and implementing labeling.
+ A minimum of 10 years directly managing teams or leading program or project management activities.
+ Advanced and proven record managing complex projects and people in a cross-functional environment
+ Excellent attention to detail and organizational skills
+ Experience in regulatory affairs and quality assurance and working knowledge of global regulatory labeling requirements in key markets/geographies.
+ Ability to multi-task and problem solve
+ Excellent writing and communication skills; ability to use advanced features of MS Word, Excel and PowerPoint
+ Strong understanding of product life cycle management requirements
+ Must be able to independently travel via car or airplane to domestic and international locations if needed. Expected travel commitment is 0-15%.
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 (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)
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 (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
Source : Integra LifeSciences
