Yogesh Vishwakarma

Senior Regulatory Affairs Specialist-QMS at Elastic Care Inc
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Contact Information
us****@****om
(386) 825-5501
Location
Mumbai, Maharashtra, India, IN
Skills

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Credentials

  • CQI and IRCA Medical Devices - Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016)
    BSI
    Apr, 2023
    - Oct, 2024

Experience

  • Elastic Care Inc
    • Canada
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Senior Regulatory Affairs Specialist-QMS
      • Dec 2021 - Present

      Document procedures for the QMS establishment per ISO 13485 & QSR 21CFR part 820. Responsible for creating technical documents for Software as Medical device (SaMD) and combination of SaMD +Hardware medical device. Assess risk to update the Risk Management File per ISO 14971 Develop and assist the regulatory strategy, phase wise strategies for the compliance of the targeted regulatory submission (US FDA) Impart the Procedural training to concern functional discipline on the implemented procedures. Achievements: Established and implemented the QMS as per QSR (21 CFR Part 820) and ISO 13485. Show less

  • Siemens Healthineers
    • Hospitals and Health Care
    • 700 & Above Employee
    • Lead Regulatory Affairs
      • Feb 2021 - Dec 2021

      Worked with Regulatory Affairs Business unit team to support on the CE mark to the Notified body during the transition phase of IVDD to IVDR regulation. Prepared the following technical documents per the IVDR Regulation: - General Safety and Performance Requirement (GSPR) - Summary of Safety and Performance (SSP) - Technical File Index (TFI) - Declaration of Conformity (DoC) Reviewed the following technical files: - Performance Evaluation Plan (PEP) - Performance Evaluation Report (PER) - Scientific Validity Report (SVR) - Analytical Performance Report (APR) - Clinical Performance Report (CPR) Show less

  • Biosense Technologies Private Limited
    • Lead Biochemistry R&D
      • Oct 2019 - Feb 2021

      Effective team member on cross functional task with Engineers on Usability of Medical Device and Software Department on the Biochemistry flow inputs. Regulatory requirements for the development of Medical devices and IVD medical devices (Whole Slide imaging system, Total Bilirubin Reader and Nephelometry reader) Developed Validation plans for the Medical device to get the study done through accredited labs (NABL Labs) Manage External Audits. Effective team member on cross functional task with Engineers on Usability of Medical Device and Software Department on the Biochemistry flow inputs. Regulatory requirements for the development of Medical devices and IVD medical devices (Whole Slide imaging system, Total Bilirubin Reader and Nephelometry reader) Developed Validation plans for the Medical device to get the study done through accredited labs (NABL Labs) Manage External Audits.

  • VOXTUR BIO LTD.
    • India
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Assistant Manager
      • Jan 2018 - Sep 2019

      Designed the standardization experiment for the development of Rapid lateral flow devices (IVD). Created Technical documents and compiled all the required document to form a Product Dossier/ Design History File as per ISO 13485 including the Risk Management File as per ISO 14971 Manage the Internal Audit activities. Achievements: Developed Rapid lateral flow for Malaria (Pan/Pf & Pf/Pv) antigen detection test, Syphilis antibody detection test and Hepatitis B antigen detection test. Designed the standardization experiment for the development of Rapid lateral flow devices (IVD). Created Technical documents and compiled all the required document to form a Product Dossier/ Design History File as per ISO 13485 including the Risk Management File as per ISO 14971 Manage the Internal Audit activities. Achievements: Developed Rapid lateral flow for Malaria (Pan/Pf & Pf/Pv) antigen detection test, Syphilis antibody detection test and Hepatitis B antigen detection test.

  • Advy chemical Pvt Ltd
    • India
    • Pharmaceutical Manufacturing
    • Research Executive
      • Feb 2013 - Dec 2017

      Product Development of Latex based Immunoturbidimetry reagents (CRP, RF, ASO, Micro-albumin, Cystatin-C, & HbA1c reagent) Performed R&D bench testing analysis for the above reagents/products (analytical performance, clinical performance and accelerated/real time stability) Documented the analytical and clinical performance reports Participated in Pre-Qualification WHO Audit Maintained the Analyte and Clinical samples used for the studies (sample bank) Design transfer to Production Department Achievements: Developed CRP, RF, ASO, Micro-albumin, Cys-C & HbA1c Immunoturbidimetry product. Successful on-field trial demonstration in different region (Jaipur & Mumbai) of the developed products Technical Documentation to have Manufacturing license (Local FDA) for the above reagents/products Show less

  • Super Religare Laboratories Ltd.
    • Scientific Officer
      • Jul 2012 - Jan 2013

      Processed the clinically positive samples per the Microbiological analysis requirements (Aerobic Department). Handled and processed the routine and RNCTP samples in Mycobacterium department Processed the clinically positive samples per the Microbiological analysis requirements (Aerobic Department). Handled and processed the routine and RNCTP samples in Mycobacterium department

Education

  • Birla college, University of Mumbai
    M.Sc, Microbiology
    2010 - 2012
  • Nagindas Khandawala college,University of Mumbai
    Bachelor of Science (B.Sc.), Microbiology
    2007 - 2010
  • Nirmala college
    HSC, science
    2005 - 2007
  • St.George high school
    SSC
    1995 - 2005

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