• Develop and maintain technical documentation as per EU MDR standards.• Coordinate and manage creation and submission of EU MDR regulatory submissions.• Implement and maintain quality management systems in line with EU MDD/MDR requirements.• Collaborate with R&D, Quality, Regulatory, and Manufacturing teams to ensure regulatory compliance.• Working as Product Owner, successfully delivered packages on End-to-End basis.• Subject matter Expert for Design Verification and Validation & Biocompatibility• Deep analysis of risks associated in overall usage for Medical Device right from production to duration of use and till disposal.• Expert reviewer for technical files.• Coordinate activities with cross-functional teams to meet project deadlines.• Managed team of ten members and successfully completed project

• Looked forward to installations, breakdown, and preventive maintenance of blood serology equipment & Luminex machines in HLA (Human Leukocyte Antigen) department.• Worked on Laboratory equipment like Centrifuge, Incubator, Pipettes, Washer etc.• Provided technical support to customers throughout India and resolving issues over call.

• Looked forward to installation, breakdowns and preventive maintenance of Computed Radiology, Direct Radiology systems, PACS.• Looked forward to preparing and scheduling AMC/CMC contracts.• Trained and managed team of field service Engineers as territory manager.• Done interfacing of Imaging results with various archiving and viewing software (RIS).• Managed team of Fourteen Engineers.• Investigated and troubleshot around thirty product service issues weekly.