Initiates projects, compiles tracker, presents Design Review of labeling changes to cross functional teams, Assembles and executes Redlines, artwork and related documentation, Summary of changes, Combine PDFs, Supplier notification notices, Validation checklists. Compiles translations, request quotes, coordinate P.O.s and implement with multi-language artworks IFUs. Extensive experience with Assembling, editing and coordinating content for Operational manuals.Demonstrated skill in creating ECOs, MCOs, ECRs, in PLM system Agile.Extensive knowledge of labeling standards and MDR requirements for Class II devices.Intermediate knowledge of Illustrator, InDesign. Adobe Pro.

• Provided input and worked closely with cross functional teams to reformat, revise content, organize edits IFUs for a new product launch in the Power Tools division. Proficient with Document Located and trained in Windchill.• Researched product labeling and produced redlines for Class I and Class II IFUs and labeling in compliance with MDR 2017/745.• Coordinated and finalized documentation, IFU specifications, BOM updates, Fist Article Inspection. Material Master requests and modifications.• Created and administered successful, accurate and timely workflows in the local PLM system Document Locator.• Coordinated pre-implementation and post implementation deliverables with departments.• Proofed translations and worked with translation vendors. Proofed First articles.• Analyzed project needs, tracking and planning,• Organized and prepared materials for graphic designers, coordinated and proofed final artwork.• Initiated and Lead project meetings.

Provide guidance and prepare PowerPoint presentations to cross functional teams tasked with the implementation of UDI Barcode requirements for legacy, Whole Blood management equipment, consumables and disposables. Worked with global RA to review labeling for compliance with global EU, China CFDA, and FDA labeling regulations for Medical Device products.Working with Quality managers to work out implementation, inventory control of labeling.Review Change orders for completeness and compliance to organizational SOPs. Coordinating information for Life Sustaining and Legacy products pertinent to GUDID database, researching 510Ks, Declarations of Conformity, Agile database.Verifying GMDN codes and assigning codes to product numbers, researching GUDID elements. LDE User for UDI elements requirements for the GUDID database and Robar database.Maintaining UDI project Label Matrix. Reviewing, preparing labeling change orders, working closely with labeling teams.Generate Assessments for RA, research queries for re-registration of class II products. Working closely with label team on manufacturing site transfer of product labeling, composing and coordinating documentation for labeling artwork, workflow prep and in country translations.Maintain RA Assessments of Labeling projects for legacy and new product lines.Project Manager for global labeling project for disposables and manuals across product lines, coordinating efforts with cross-functional teams to align with objectives, structure costing, inventory control, Quality planning, and implementation activities. Provided gap analysis, prioritization, quantification reports and project tracker. Provide gap analysis on Provided supportive submission materials labeling changes for international registrations.

• Processed the approval of engineering change orders through Agile PLM. • Responsible for daily processing of documentation that supported the Documentation System including but not limited to; SOP’s, Product Specifications. • Reviewed packages for accuracy and conformance to established guidelines, polices, and practices.• Advised and assisted in composing technical documents with document creators, and engineers.• Routine duties that support the control and retrieval of the various documents• Processed controlled documentation within a manual system.• Reviewed packages for accuracy and conformance to established guidelines, polices, and practices.• Advised and responded to queries on document status by interfacing with document creators, and engineers.• Performed Data extraction, manipulation of data for reports. • Efficiently and effectively organized and tracked assigned projects for issuance, reconciliation and communicated statuses. • Support team improvement projects.

• Coordinating supporting Artwork, Source files, Fabricated Drawings (CAD Drawings) for Engineering Change Orders, ensuring accuracy, for surgical and in-vitro diagnostic medical device product labeling and Instructions for Use.• Assisting in Project Management; organizing and maintaining timeline spreadsheets and project tracking forms in Excel, clarifying tasks and objectives, coordinating, analyzing and coordinating documentation to determine accuracy, compliance and relevancy.• Interpreting, analyzing and applying FDA, GHS, UDI Standards to labeling and IFUs.• Analyzing MSDS data in conjunction with GHS standards. • Coordinating signatory documentation for translations of manuals and labeling with vendors, supporting documentation, P.O. requests and approvals, Validation Activities Checklist, Product Labeling Initiation forms, Translation Approval Forms, supplemental explanatory documentation. • Originating preliminary and production Engineering Change Orders in Agile, attaching documents, creating Bill of Materials and researching queries, in accordance with Standard Operating Procedures and other organizational conventions.• Coordinating and communicating the workflow of files with Supervisor, Graphic Designers and members of the team i.e. regulatory, R&D, EHS and Marketing.Assisting Technical writers with composing/revising IFUs and Package inserts.• Responsible for mark ups for revisions, Combined PDFS, adding watermarks in Acrobat 10 Pro, minor edits in Adobe Illustrator and Indesign.• Researching requirements for international standards relating to medical device product labeling such as Global Harmonized Standards, IEC 60601 3rd edition. • Assisted in updating corporate website. Converting PDF’s to jpegs and uploading to Gateway.• Acquiring Abstracts, copyright permissions, maintaining EndNote libraries for Medical information pertaining to product lines.• Extensive use of Microsoft Office Word, Excel, Agile, Adobe Illustrator, Indesign,

• Centralized and compiled training documentation and performed data entry, maintained and updated Access database and hard copy binder library.• Created hard copy training binders files for individual employees. Reformatted training modules and oriented new hire employees. Generated reports and queries.• Assisted in the compilation of regulatory Technical Summaries for acquired products; outlined the 11 essential requirement to include references and standards, combined product testing reports, part numbers and Intended Use descriptions.. • Assisted regulatory in researching and compiling documentation for products affected by IEC 60601-1 3rd Edition• Rebranded and revised labeling and user manuals, prepared supporting documentation, Mark ups, proposed documentation, for ECO process using Acrobat X Pro and Framemaker.

• Training Designate maintained files and the data entry of controlled documents • Assisted in document release workflow of SOPs; data entry and the maintaining hard files• Ran Monthly percentage reports from ISOtrain Production, generated ad hoc reports converted and exported documents to Adobe PDF format, managed Excel spreadsheets • Assisted personnel in determining training requirements and good documentation procedures• Documented training procedures, used in generating training programs for personnel • Coached and mentored five departments in training needs in attaining training requirements, maintaining goals.• Maintained Training Presentation Files of Subject Matter Experts.• Created flowcharts in Visio of department procedures• Assisted in Archiving of preclinical and clinical studies

• Assisted the Document Control Coordinator in processing technical documents• Aided in the transition of technical documents from hard copy to an online system• Created, formatted and linked documents in Word and Excel• Indexed and revised outdated documents to meet state standards• Filed, indexed, and proofread MSDS, casting specs, and test methods• Maintained focus, accuracy and attention to detail• Scanned, filed, and copied documents• Self directed and able to grasp the process quickly