Aimee Wright Email & Phone Number

New Brunswick, New Jersey, US

• Leads establishment of end-to-end processes and systems for MedTech labeling customization, in partnership with Regulatory Affairs, Supply Chain, Q&C and Deliver functions, to ensure compliance of Medical Device.
• Support the implementation and sustainability of the multi-year program associated with Right Stage Customization system & processes as the Quality Workstream Leader.
• Manage sustainability for Label Customization process globally.
• Assist with label customization process/system to ensure design/format verification performed, and business & supply chain needs are met with system functionality.
• Collaborate with Supply Chain, Regulatory Affairs, Deliver and Quality partners to integrate ensure Labeling Customization strategies align and support business strategies.
• Develops, leverages, and implements forward thinking innovation strategies and capabilities related to Labeling Customization.

Warsaw, Indiana, US

• Manage an internal and external team of 37 team members within the organization.
• Introduced complete End-To-End Labeling System, Process and Strategy o Company Global Subject Matter Expert for Labeling.o Project Manager Lead for researching, planning and implementing the ROBAR Global Labeling.
• Label Content & Labeling Processeso Owner of global process/procedures for Label Development for Medical Device, IVD and Pharmaceutical/Drug devices.o Maintain process/procedures for acquiring translations for Labels.
• Project Lead for European Medical Device Regulation & In Vitro Diagnostics Regulation for Global Labelingo Developed coordination between Business and Distribution Center for Economic Operator verification process.o.

Warsaw, Indiana, US

• Assist, coach, engage with and lead my team that performs daily labeling job tasks, as well as help with questions, concerns, issues and harmonization efforts as we innovate, improve and find 'best practices' of tasks.
• Subject Matter Expert for Global Labeling & Labeling Systems.o Business System Owner for ROBAR Global Labeling System & Prisym Medica.o Project Manager Lead for researching, planning and implementing the ROBAR Global.
• Subject Matter Expert for Label Content and Labeling Processeso Assist and coach other Labeling Specialists when generating, revising and assuring the integrity of label content for product manufactured and.
• Create and maintain corporate and local site processes and procedures in order for my team to develop and design label formats, load and maintain label content, prepare, publish and release labeling documents.
• Own, research and implement all Global Labeling CAPA and IE’s, as well as assist with other departmental or business CAPA and IE’s.

Warsaw, Indiana, US

• Assist, coach, engage with and lead my team that performs daily labeling job tasks, as well as help with questions, concerns, issues and harmonization efforts as we innovate, improve and find 'best practices' of tasks.
• Subject Matter Expert for Global Labeling & Labeling Systems.o Project Manager Lead for researching, planning and implementing the ROBAR Global Labeling System into all Zimmer Biomet Design Authority sites. o Subject.
• Subject Matter Expert for Label Content and Labeling Processeso Assist and coach other Labeling Specialists when generating, revising and assuring the integrity of label content for product manufactured and.
• Create and maintain corporate and local site processes and procedures in order for my team to develop and design label formats, load and maintain label content, prepare, publish and release labeling documents.
• Own, research and implement all Global Labeling CAPA and IE’s, as well as assist with other departmental or business CAPA and IE’s.

Warsaw, Indiana, US

• Work daily with IT, Regulatory, Development, Production Packaging, Quality, Sourcing, Supplier Quality and Trade Compliance to determine paths forward to label product appropriately and in compliance with US, EU, UDI.
• Subject Matter Expert for Global Labeling & Labeling Systems.o Perform validation of ROBAR Global Labeling System within Zimmer Biometo Design label templates in ROBAR.o Zimmer Biomet system administrator for ROBAR &.
• Generated, revised and assured the integrity of label content for product manufactured and distributed by Zimmer, Inc. o Created label content for both Domestic and European labels, for standard line product as well as.
• Lead for all Global Labeling projects.o Project Manager Lead for rolling out ROBAR Global Labeling System to all Zimmer Biomet manufacturing sites. o Project Manager Lead for implementing all Zimmer Biomet sites.

Warsaw, Indiana, US

Collaborate with Regulatory Affairs, Marketing, Legal and Development on Labels and Package Inserts (IFU).Subject Matter Expert for Robar Labeling System. System Admin for Robar Labeling System.Label CreationCreate and maintain label templates. Assist with validation and implementation of Robar Labeling System within Zimmer Biomet and vendors.Assist with.

Warsaw, Indiana, US

Conducted all field actions at Warsaw, Puerto Rico, Ireland and New Jersey reconstructive & trauma facilities. Assisted with field actions at Spine, Dental and orthopedic soft goods facilities. Collaborate with New Product Development, Quality Assurance, Brand Management, Regulatory Affairs, Regulatory Compliance and Legal to determine the root cause and.

Warsaw, Indiana, US

Handle all implant recalls & market withdrawals.Complete MedWatch and Vigilance Reports to be submitted to FDA and various international Competent Authority within 30 day due date on all adverse & serious injury events.Document all Product Experience Reports into internal complaint handling system. Handle & respond to all inquires received from FDA and.

Warsaw, Indiana, US

Handled all transportation issues with carriers including filing claims.Compiled numerous month end reports to be disbursed throughout Zimmer Upper Management including FedEx Accrual and Fill Rate. Tracked all First Overnight shipments resulting in a reimbursement of $38K for 2007.Assist with and coordinate all Distribution Center Tours.Create and maintain.

Warsaw, Indiana, US

Obtained all documentation needed for product complaint investigations. Assisted with technician and engineering evaluations of product complaints.Prepared memos to inform of completion of complaint investigation. Provided all monthly metrics of complaints and confirmed issues. Assisted with letter notifications of field retrievals and recalls.Completed.