Sarath Kumar B Email & Phone Number

I have 10 years of experience in Medical Device regulations (Both US FDA & EU MDR) and associated activities like Validation, FMEA, Risk management (ISO 14971), Labeling (ISO 15223, 7000), Packaging (ASTM/ISTA), Bio-compatibility (ISO 10993), Material Assessment, Production & Purchasing which include 2 years of experience in ERP, PLM’s & 1 year of Planning and Quality Analyst experience in parts manufacturing and on-site coordinator at Customer location for 8 Months. Roles and Responsibilities Regulatory Senior Engineer Reviewed the EU MDR Gap Assessment, Remediation plan and STED (Technical Documentation) compilation from project team and coordinating with stack holder (cross functional team) for approvals. Complete Process and Equipment Validation including DV, FAT, IQ, OQ, PQ, RTM, URS, SPD protocol development, implementation, and report completion per timelinesLeading and executing PFMEAsParticipate in cross functional teams consisting of Supplier Quality, Supply chain and Design in Supplier qualification projects to meet Quality, Cost, and service requirements.Project : EU MDR STED file compilation Developed and maintained collaborative relationships with interdepartmental team, external consultants & suppliers.Prepared harmonized testing procedure for primary packaging seal strength study in reference to ASTM F88/88M.Classified the Medical devices as per new MDR regulation and writing the respective justification for the same.Evaluated the existing Packaging system and its shipping Validation reports complies to the latest standard ISTA 2A and ISO 11607.Fetched the Design History Files from customer PLM(Agile) and Document control and providing the same to project team to perform the STED file compilation. Performed the standard assessment and identified the harmonized standards with reference to EU MDR. Project : EU MDR for Class I devicesPrepared Bio-compatibility Safety Evaluation Plan and Reports for Medical device as per ISO 10993Red-lined the labels, IFU and operating manual based on the gap assessment performed for EU MDR 745/2017Preformed labeling symbol gap assessment with client as per ISO 15223.Routed the red-lined labels on the agile(MCO - Manufacturing change order) for CFT approval. Prepared Trace-matrix for entire system and uploaded in the agile for approval with CFT .PC Skills: Regular use of MS office (outlook, word, excel, Project, PowerPoint, MS project), AutoCAD Familiar with Catia, Pro-E, Adaptive, wind-chill, JDE, Tungsten, Agile, ERP and SAP environment