Experience

Vigocare

• India
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Specialist

  • Mar 2023 - Present

  - Tech Lead and Executing the RA Deliverables like GSPR LoAS, DOC, Tech Doc, - Peer/expect review in Design History Files(DHF) and Technical Documentation. -Performing Gap Analysis & Remediation of Risk Management files like Risk Management Plan, DFMEA and UFMEA in compliance with EUMDR, ISO 14971, and PMS (Post Market Surveillance). - Tech Lead and Executing the RA Deliverables like GSPR LoAS, DOC, Tech Doc, - Peer/expect review in Design History Files(DHF) and Technical Documentation. -Performing Gap Analysis & Remediation of Risk Management files like Risk Management Plan, DFMEA and UFMEA in compliance with EUMDR, ISO 14971, and PMS (Post Market Surveillance).



Tata Elxsi

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Specialist

  • Apr 2022 - Feb 2023

  * Performing as a Tech Lead and Executing the RA Deliverables like GSPR LoAS, DOC, Tech Doc, Summary Tables Etc. Peer/expect review. * Reviewing and updating the changes in Design History Files(DHF) and Technical Files for conformance to applicable requirements. * Performing Remediation of Risk Management files like Risk Management Plan, DFMEA, UFMEA, and PFMEA) in compliance with EUMDR, ISO 14971, and PMS (Post Market Surveillance). * Co-coordinating between the CER Team and client for CEP/CER doubts and document completion updating and & monitoring daily progress on the files and keeping track of progress for completion. * Authoring and Reviewing the Usability Engineering file. * Writing and reviewing the Design Intent Document and Design Traceability Matrix. * US FDA Submission Activity. * Writing Technical section(RA) in Clinical Evaluation Report. * Knowledge of complaint-handling activities. Show less



MakroCare

• United States
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Senior Product Quality Engineer

  • Apr 2019 - Mar 2022

  • Experienced in EU-MDR transition of different medical devices from MDD to MDR 2017/745. • Gap Assessment between GSPR and ERC as per MDR-2017/ 745, Gap Assessment of Standards applied /mentioned in ERC and New standards to be followed/Harmonized standards as per MDR requirements. • Technical Documentation as per EU MDR 745/2017 Annex II. • Ensuring Regulatory requirements in the Risk Management file, Usability Engineering File, and Design. • Communicating to cross-functional teams regarding labeling and Clinical for • Regulatory Requirements. • Experienced in writing the Technical Aspects of Clinical Evaluation Plans and Reports. • Experienced in writing the PMS Report and PSUR Report. • Knowledge of CE Marking Submission. • Knowledge of USA FDA Submission. Show less



GVK Emergency Management and Research Institute

• India
• Hospitals and Health Care
• 200 - 300 Employee

• Biomedical Engineer

  • Dec 2014 - Apr 2018

  • Servicing Medical Equipment like Multi Para Patient Monitors, AED, Ventilators, Infusion Pumps, Syringe pumps, • Validation and Scrutinize of the Medical Equipment, Medical Consumables and Non-Disposable items for National Tender and Government Tenders. • Based on the Technical Specification, validating Medical Equipment & Medical Consumables for pan India operation. • Acted as liaison officer and provide technical support to all operating states. • Monitored the assembly procedures in prototypes, equipments, and tested samples to assess its efficacy. • Train Emergency Management Technician and other medical personnel on the proper use of equipment. • Participated in the purchase committee and oversee the vehicle fabrication, design and testing of systems after installation to ensure performance as per the safety norms. • Documenting the Medical Equipment specification for the products. • Monitoring and handing a team of Bio Medical Engineer for pan India. • Stock maintaining of Medical Equipment & Consumables. • Operational and Inventory maintenance on repairs. Show less



SCHILLER India

• India
• Medical Equipment Manufacturing
• 200 - 300 Employee

• Customer Support Engineer

  • Oct 2011 - Nov 2014

  • Installation and Demo of medical equipment, at various cities • Operational and maintenance Training given to Technicians and biomedical Engineers • Receiving and resolving complex issues and meeting customer needs • Analyzing the problems and providing the solutions at customer place. • Provided customers with regular reports and feedback on their service requests. • Maintaining the MIS reports and regular updating of CRM. • Installation and Demo of medical equipment, at various cities • Operational and maintenance Training given to Technicians and biomedical Engineers • Receiving and resolving complex issues and meeting customer needs • Analyzing the problems and providing the solutions at customer place. • Provided customers with regular reports and feedback on their service requests. • Maintaining the MIS reports and regular updating of CRM.