Performed gap assessment on existing products and remediate those gaps as per SOP,  EU MDR and FDA regulations.Update the risk management file (RMP, RAW/PC, PHA, FMEA, RMR) based on post production reviews, compliant, regulatory requirements and ISO 14971.Prepared regulatory documents like TD, GSPR, DoC for the notified body submission and knowledge on technical file compilation.Worked on design and development files like DDP creation, Design input, design output, Verification & Validation documents, DHF index, trace matrix/IOVV, User Need.Strong verbal and written communication, project management, proficient interaction with stakeholders/customer, strong technical skills and well experienced on Microsoft office (Excel, PowerPoint, Word).Based on experience of standard assessment, gained knowledge on ISO 13485, ISO 14971, EN 62366-1, IEC 62304, ISO 20417, ISO 15233-1, 21 CFR 820.30Carried out the redlining activities of IFU and labels.Created the usability engineering file/UOUP in accordance with Annex C of IEC 62366-1.