Nagalaxmi Movva

Working as Senior Engineer for Medical Device Registration project and Supporting Project quality Audit activities

• Role involved in GSSD (Section 1 to 8) updates to make it compliant to EU MDR
• As per EU MDR Certificate availability and Document authentication Completion, Country Specific submission documents finalization and upload in Calyx RIM
• Country Specific documents(APAC and CEMA regions) drafting and communication with Geo RA for queries
• Working as Offshore Expert reviewer, responsible for reviewing and uploading final GSSD in Regulator Approval Database (RAD) Application
• MDD and MDR Labels review and Creation of Label change table for Application submission
• CAPA analysis for identified gaps in Project
• Connecting with QA Team for Monthly Project Review meetings
• Updating Internal/Customer Review Defect Density and Training Compliance data in KPI sheet
• Responsible for handling Project quality related tasks and Audits
• Developed Excel Automation for Country Certificate renewal activity resulting in 50% efforts reduced for email communication
• Familiar with Statical Software Tools(Minitab).

• Worked as Senior Associate, Handled Six Medical Device Registration projects for India, Brazil and South Korea
• Product Understanding Document preparation
• Product Classification as per Indian Medical Device Rules 2017
• Led end-to-end medical device registrations across global Regions
• Medical Device registration support for India and South Korea
• Device Master file and Plant Master file Compilation
• Dossier preparation for Import License application Submission
• Country Specific Documentation Preparation and Sharing Documents for Apostille /Notarization
• Queries Discussion and Project related communication with Client
• Medical Device Import License application submission in CDSCO portal
• Product Documents Review and Email communication between Client and Consultant
• Conducted monthly training sessions Internally and attended Knowledge sharing webinars.

Worked as Lead Engineer for Medical Device Regulation Project of Johnson & Johnson

• Product release in Regulatory approval Database(RAD)
• Declaration of Conformity (DOC) Verification and Validation
• 510(K) submission verification and validation
• Knowledge on 21CFR part 820 and US FDA regulatory requirements
• Review of Labels to meet regulatory requirements of international markets
• CAPA Analysis for released DOC Licenses
• Good in communication, analytical skills and experience in working with global R&D development and interact with multiple stakeholders at various levels in different geography and time zone

Worked as Member Technical Staff in MDR gap assessment project for Abbott Laboratories

• Role involved in MDR2017/745 gap assessment for existing medical device Directive (MDD 93/42/EEC) Documents. Performed MDR gap Analysis for IFU, Label and Risk Management sections
• Risk management file, DFMEA and PFMEA Gap Analysis
• Worked as Label designer for converting all SJM products to Abbot Labels
• Compile any corrections, changes, errors or inconsistencies using Adobe Acrobat and Microsoft Excel
• Transferred Labels data from Blueprint to SAP MD by eliminating obsolete product data.

• Worked as Graduate Engineer Trainee(GET) for Designing HPDC Dies of TVS , Honda and Tyche Die Cast
• Responsible for understanding customer requirements and preparing statement of work as per input received
• Preparation of Inspection Report for Casting Model
• Making necessary design changes in VISI CAD and Creo
• Preparing BOM and 2D Drawings for Die components in AutoCAD
• Preparation of PPAP Documents and Inspection Reports
• Attended Shop floor training and Quality Inspection training.