Ranjith Kumar

Experience

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  TBS INDIA TELEMATIC AND BIOMEDICAL SERVICES

  Jan 2021 - Sept 2021

  Service Engineer
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  AIC-AMTZ MediValley

  Sept 2021 - Jan 2022

  Biomedical Engineer
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  Tata Consultancy Services

  Jan 2022 - Dec 2022

  Regulatory Affairs Associate
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  Nanoshel Healthcare Pvt Ltd

  Dec 2022 - now

  QA/RA Manager

  • Familiarity with USFDA (21CFR Part 820), EU MDR 2017/745, ISO 13485, ISO 14971, Complaint management, Complaint investigation, Risk analysis, and CAPA initiation Complaint closure and submission of the MDR• Supporting to Post Market Surveillance (PMS) activities such as complaints handling, risk assessment, trend analysis report, creation of PSUR and process improvement etc.• Creating the AER, DT Evaluation, and Medical Device Reporting (e-MDR) for incident submission to the FDA using the TrackWise tool• Doing the investigation process, analysing the Root Cause of the incident, writing the investigation summary report, and needing to find CAPA required or already taken• Complaint records will be coded with IMDRF Annex Codes, and the FDA codes should follow with the Risk Assessment and Failure Mode Codes• If the complaint is reportable, an MDR has to be created. In MDR, a complaint is reported as a Malfunction report, and the complaint contains adverse event information for a reportable serious injury (SI) or death (D); a supplement changing the status to an Sl or D will be prepared and submitted• Evaluating the Risk assessment, Device History Record (DHR), Complaint History Record (CHR), and CAPA for incidents involving Medical devices on the SAP tool• Preparing the Trend Analysis Report, risk-benefit analysis, and CAPA for the product to ensure compliance with EU MDR regulation and performing MDR Gap assessment. Show less