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 products commercialized / distributed globally. • 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.• Quality oversight for Electronic IFU and Patient Information Leaflet system.• Support the implementation and sustainability of the new global process for Electronic IFU deployment.• Workstream Leader for End-to-End MedTech Labeling process improvements.• Monitor processes improvement and evolutions through NC, CAPA and Escalations trends, continuously improving the process based on trends & root causes identified.

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 System into all Zimmer Biomet Design Authority sites, manufacturing sites, vendors and suppliers. o Cost savings initiatives of working with translation vendors & using translation memory and reducing preprinted IFU’s by moving to Electronic Labeling.o GTIN Allocation, Publishing to FDA GUDID & GDSN systems, along with set up for publishing to EUDAMED.• 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, IFU’s, SSCP’s, Surgical Techniques & IFP’s and implementation of the documents.o Strategize with Sourcing and consuming sites when implementing revised IFU’s to reduce scrap.o Strategize, assist, and coach team members when generating, revising, and assuring the integrity of label content for product manufactured and distributed. o Ensure labeling content meets UDI, US, EU and local site requirements. o Work daily with IT, Regulatory Affairs, Development, Marketing, Production Packaging Operations, Quality, Sourcing, Supplier Quality, and Trade Compliance to strategize on various projects.• 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 Implemented batch determination process for when product changed to MDR compliance to assist with batch segregation and inspections.o Under MDR cadence, implement a harmonized label design that allowed for labeling data attributes within labeling system harmonized with the use of a symbol glossary.

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 performed. Work daily with IT, Regulatory, Development, Production Packaging, Quality, Sourcing, Supplier Quality and Trade Compliance management to determine paths forward to label product appropriately and in compliance with US, EU and other regulatory requirements.• 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 Labeling System into all Zimmer Biomet Design Authority sites, manufacturing sites, vendors and suppliers. o Subject Matter Expert for Labeling Printers used with Global Labeling Systems.o Perform ROBAR validation within Zimmer Biomet and vendors.o System administrator for Global Labeling Systems; system configuration, label formats, reviewing and approving all IT tickets to grant access into all local Global Labeling Systems.• 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 distributed. o Ensure labeling content meets UDI, US, EU and local site requirements.• 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 performed. Work daily with IT, Regulatory, Development, Production Packaging, Quality, Sourcing, Supplier Quality and Trade Compliance management to determine paths forward to label product appropriately and in compliance with US, EU and other regulatory requirements.• 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 Matter Expert for Labeling Printers used with Global Labeling Systems.o Perform ROBAR validation within Zimmer Biomet and vendors.o Project Manager Lead for rolling out ROBAR Global Labeling System to all Zimmer Biomet manufacturing sites, vendors and suppliers. o System administrator for Global Labeling Systems; reviewing and approving all IT tickets to grant access into all local Global Labeling Systems.• 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 distributed. o Ensure labeling content meets UDI, US, EU and local site requirements.• 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 and other regulatory requirements. • 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 & Prisym Global Labeling Systems.• 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 custom, research and clinical product. o Compiled and organized all terminologies to be sent for translation. o Interacted closely with the Regulatory Team and members of other Departments to identify and evaluate label issues throughout the life cycle of a product. • 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 labeling data onto ROBAR Global Labeling System. .

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 launch of Global Label concept. Department lead for DePuy Trauma acquisition into Biomet Trauma labeling and IFU’s.Review and approve labels. Labeling data transfers/conversions.

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 scope of product problems.Effectively summarize outcomes of team meetings with previously mentioned departments to compose Field Safety Corrective Actions (FSCA) to be submitted to Competent Authorities.Proficient in FDA Regulations: 21 CFR Parts 803, 806 and 820.Proficient in MEDDEV Regulations.Create all field action notifications.Handle & respond to all inquires received from FDA and Competent Authorities.Assist with creating/pulling necessary data for FDA Correction & Removal Reports. Assist with all corporate, BSi, International Competent Authority and FDA audits.Ensure CAPA’s are initiated and completed pertaining to field actions.

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 Competent Authority.

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 all Zimmer Corporate & Distributor FedEx Accounts.Assist with yearly budgets and retrieving information on monthly budget reports.Create all memos, forms, and presentations for supervisors within Distribution.

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 MedWatch and Vigilance Reports to be submitted to FDA and Competent Authority.Entered all Product Experience Reports into complaint handling system.