Medical Device Project Coordinator

Wildrosenallee *, ***** Siegen Germany, Phone number : +49-152*-*******,

Email: ************@*****.***

Raju Udas Shrestha

Professional Summary

Accumulated over 9 years of experience working as a Project Coordinator with a comprehensive background and executing projects in the medical device and manufacturing industries.

Over 7 years’ experience in accounting and finance with a focus on Banking and INGO sector.

Executed and managed multiple franchise EU MDR labeling and Late Stage Transformation projects within the MDR Data Operation team for medical device products.

Managed multiple SAP/UDI Contract Manufacturing projects for medical device and medical supplies products.

Excellent verbal and written communication skills.

Capable of working Flexible hours.

Experience of working in cross functional teams.

Capability to learn and adapt to New Systems and Technologies quickly and effectively.

Ability to work well independently as well as in a groups and the capability to prioritize work.

Highly detail-oriented with strong problem- solving skills.

Proficient in adhering to company/organization policies. Education

Master of Business Administration in Accounting- Johnson and Wales University, Providence, RI, USA

Bachelor of Business Studies in Finance-Tribhuvan University, Kathmandu, Nepal Specialist

Project Management, Medical Device Product Labeling, Product Lifecycle Management, Data Management, Cross- Functional Team Leadership, Project tracking, Label Proofing, Maintenance Coordination, Strong Organization skills, Accounting and Finance, & Supply Chain, Procurement Skills

Excellent PC Skills (Microsoft Office Package), RSC (Right Stage Customization), Product Lifecycle Management - WindChill, ADAPTIVE, ERP Launch Pad - SAP(P01), Oracle AGILE, SharePoint, SAP(ECC) e-ledger, PeopleSoft, JD Edwards (ERP), Insight, Cash Pro, HFA, AS400, DART(A/P software), Documentum, ARIBA (e-Sourcing tool), MIS (Material Inventory System), Lotus Notes, Fibu (Financial Book Keeping Utility), Pro-Miss (Project Management System).

PROFESSIONAL EXPERIENCE

Project Coordinator - MDR (Medical Device Regulation) Data Operations 09/ 2021-11/ 2023 Johnson & Johnson, Raynham, MA, USA (Remote)

Managed and executed of multiple franchise labeling (product label and/or IFU) and packaging configurations to comply with EU MDR Labeling language requirements.

Utilized the Product Lifecycle Management (PLM) -WindChill system to create and execute Change Requests and Change Notices for tracking and approval of label revisions through the change workflow process and ensure that the label are aligning with the project plan.

Demonstrated proficiency in proofreading redline labels against approved documentation.

Updated and maintained the status of each job in accordance with the applicable project plan and job tracker.

Escalated issues and delayed activities to the Leads as necessary.

Verified the completeness and accuracy of product data from Franchise requestors by creating MSPTR

(Master Specification Product Requirement) Forms and processed through the PLM system.

Effectively collaborated and remain aligned with MDR E2E Stakeholders including Regulatory Affairs, Quality Engineers, Labeling Design Team, Deliver Sites (Distribution Centers) for planning and processing.

Created Intake form for each MSPTR form and submitted it to Distribution Centers for printing labels and IFU.

Raju Udas Shrestha

Wildrosenallee 8, 57078 Siegen Germany, Phone number : +49-152*-*******, Email: ************@*****.***

Established and maintained active product codes by creating component assignments and component masters by using the RSC (Right Stage Customization) system following an approval process.

Uploaded European MDR product master data into the ERP SAP P01 system for labeling compliance at the European distribution site.

Created, managed, and processed transformation orders executed within a deliver transformation site by using Right Stage Customization system’s Product Transformation Module.

Regularly monitored and responded to emails, and performed required tasked in line with the project’s demand.

Executing data entry tasks and overseeing databases.

Tracked and reported the project progress, issues, and risks Project Coordinator –Contract Manufacturing SAP/UDI Project 11/2015 – 04/2018 Medtronic, Mansfield, MA, USA

Managed and executed multiple medical device SAP/UDI GS1 labeling compliance project for contract manufacturing companies, ensuring strict adherence to US FDA mandatory requirements.

Supervised, and managed project performance metrics throughout the labeling design process, collaborating with cross- functional team including Graphics team, Supply Quality Engineering, Logistics, Regulatory Affairs, and Operations.

Preparing and maintaining CMs project components per the UDI CM Playbook.

Formulated project plans using Microsoft Project and maintained accurate representation within the CM Databases.

Led CDP (Change Development Process) Project for each CM projects, managed the workflow process and overseeing project schedule, project deliverables, and maintained relationship with CMs.

Escalated issues and delayed activities to the management team in timely manner.

Maintained working knowledge of company processes, procedures, and UDI standards to create high quality deliverables.

Collaborated with cross-functional teams to ensure the timely completion of project deliverables according to the designated timeline.

Arranged meetings with CMs and team to relay the information to related departments and team members as regular basis.

Artwork/Label Project Coordinator, Lead - UDI Project 05/2014- 10/2015 Medtronic, Mansfield, MA, USA

Led an artwork team including designers, coordinators and drafters to achieve UDI compliance in accordance with FDA requirements for contract manufacture companies.

Created and managed multiple reports related to the status of artwork updates for high-level management.

Collaborated cross-functional teams, including Regulatory Affairs, GBU Marketing, Engineering, and Quality Control to ensure that all artwork revisions comply with FDA regulations.

Conveyed essential information to the artwork design team in a timely and accurate manner, ensuring the UDI compliance of the current label artwork.

Reviewed and redlined artworks necessitating UDI revisions and delegated job setup to the design team.

Served as the primary contact for any job-related inquiries and concerning label changes.

Conducted proofreading for artwork changes and routed them to the relevant approvers via the Agile Approval system.

Responsible for resolving issues related to rejection and managing the approval process.. Financial Analyst 05/2013 - 04/2014

Bank of America, Providence, RI, USA

Raju Udas Shrestha

Wildrosenallee 8, 57078 Siegen Germany, Phone number : +49-152*-*******, Email: ************@*****.***

Managed, reviewed and processed of Stop Payment/Cancellations for invoice payments in Corporate Accounts Payable using the Bank SAP system, demonstrating organizational control over project activities and facilitating the issuance of reissued and non-reissued checks and invoices.

Entered General Ledger entries into the e-ledger system, prepared FDES reports, and delivered project plans with limited direction from project managers, showcasing an ability to analyze and initiate stop payments as necessary.

Effectively managed multiple priorities in a transaction-driven environment, updated metrics for stop payments and cancellations, and demonstrated proactive communication and collaboration with internal and external stakeholders to address and resolve issues. Procurement Analyst 07/2012 – 04/2013

Acushnet Company, Fairhaven, MA, USA

Proficiently managed end-to-end procurement processes, creating and processing purchase orders for footwear and gloves with necessary approvals, and utilizing PeopleSoft for updates such as promise dates, due dates, quantity, and pricing.

Conducted thorough analysis through ERP system queries, generating daily and bi-monthly reports on inventory, out-of-stock items, backorders, and upcoming purchase orders, contributing to effective budgeting and forecasting processes.

Ensured accurate and timely payment processing by verifying and confirming freight invoices, reconciling purchase orders, and managing outstanding invoices, while also overseeing container priority shipments and Special Make Up (SMU) purchase orders.

Maintained comprehensive records, updating and managing sales history and product analysis reports at month-end, and collecting international forecast reports monthly for informed decision-making. Project Coordinator – Global Sourcing and Rebranding Project 02/2010 – 06/2012 COVIDIEN, Mansfield, MA, USA

Managed and executed the rebranding of packaging artwork for contract manufacturing companies, obtaining necessary approvals and overseeing the launch of rebranded packages and labels.

Led effective collaboration with cross-functional teams, including Sourcing, Graphics, Suppliers, and designers, to address and resolve issues related to packaging artwork changes.

Established and maintained a comprehensive tracking system for the artwork proofing process, ensuring adherence to company requirements and facilitating communication with internal and external stakeholders.

Demonstrated top-level project management skills by creating, updating, and tracking project metrics for analysis, managing obsolescence inventories with contract manufacturers, and effectively communicating with management through issue logs and weekly reports.

Collected dieline information for each package level from the contract manufactures and supplied it to the graphic design team for the creation of new packaging artworks.

Worked in collaboration with supplier quality engineers to update the product specifications that aligned with the new artwork on the packaging level and communicated to the contract manufacturing companies.

Managed and monitored project milestones through performance metrics.

Updated and reviewed accurate price of the products into ERP systems. Accounts Payable Analyst 11/2009 – 01/2010

Covidien, Mansfield, MA, USA

Effectively managed the transition of accounts payable activities to a new system for over 100 Medical Supplies suppliers, ensuring accurate and timely processing of invoices for payment.

Demonstrated proficiency in problem resolution by addressing issues in the AP governance queue in the DART system, reviewing transactions for discrepancies, and conducting a three-way match process for invoices.

Implemented efficient communication channels with suppliers, internal logistics, and buyers, providing timely payment information through weekly reports, confirming checks/Electronic Funds Transfers (EFT), and creating a tool for analyzing supplier payments during the transition to a new payment system. Raju Udas Shrestha

Wildrosenallee 8, 57078 Siegen Germany, Phone number : +49-152*-*******, Email: ************@*****.***

Accounting Assistance 07/2008 – 10/2009

NICKEL CORPORATION, Providence, RI, USA

Managed daily invoice transactions, recording sales and expenses, and maintained the purchasing process for accurate financial tracking.

Implemented proper controls and systems to effectively manage inventory levels and conducted billing processes, ensuring smooth operations.

Ensured accuracy in financial reporting by preparing journal entries, general ledger, and quarterly financial reports.

Demonstrated strong financial management skills by tracking, reconciling, and facilitating accurate and timely payments for outstanding invoices, while also managing reimbursement processes and preparing monthly balance sheets.

Accounting Assistant 05/2001 - 01/2005

WATER RESOURCE MANAGEMENT PROGRAM (WARM-P)/HELVETAS, Nepal

Oversaw comprehensive financial functions including Account Bookkeeping, Accounts Receivable, Payables, General Ledger, trial balance, and bank reconciliation for the organization.

Contributed significantly to financial reporting by supporting the preparation of Quarterly Financial Reviews and Annual Financial Reports.

Demonstrated proficiency in budgeting, forecasting processes, and internal audits while efficiently managing the organization's procurement activities, including creating, collecting, and comparing quotations, initiating purchase orders, and conducting cost analysis of inventory for various suppliers.

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