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Yahavi Arumaikkannu

Yahavi Arumaikkannu

Downstream Analyst

Followers of Yahavi Arumaikkannu1000 followers
location of Yahavi ArumaikkannuCroydon, England, United Kingdom

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  • Timeline

  • About me

    Medical Device –Regulatory Affairs Specialist

  • Education

    • Arunai Engineering College

      2015 - 2019
      Bachelor of Technology Biotechnology

      Activities and Societies: NCC PROJECTSDevelopment of Novel Anti – Biofilm formulation comprising synergistic combination of phytochemicals for Implant Coatings.Antioxidant, Anti-microbial, GCMS analysis of N.arbor-tristis.Antioxidant, Anti-microbial, GCMS analysis of S.nigrum.Recombinant Cloning of Food enzyme.

    • Alagappa University

      2022 - 2024
      Master of Business Administration - MBA Technology Management

      Completed MBA-Technology management through distance education learning program.

  • Experience

    • Swim Biopharma

      Apr 2019 - Feb 2020
      Downstream Analyst

      Worked in the production of Bio-enzyme L-asparaginase.Develop and maintain SOPs as required to assure consistency and compliance.

    • HCLTech

      Mar 2020 - Dec 2022
      Medical Writer

      Worked in PMS complaint handling project for Class 2b medical devices.Responsible for processing product complaint files globally from Intake status to closure; including coding for USA, EU, AUSTRALIA, CANADA, CHINA and closes the files appropriately within due date to meet metrics.

    • L&T Technology Services

      Feb 2023 - Sept 2023
      Medical device complaints handling Specialist

      Experience in Post Marketing Vigilance reporting of Philips Respiratory devices. Communicate with clinicians related to case events to evaluate case procedures and other clinical information’s that are related to complaint vigilance. Co-ordinates and assists with corrective actions taken regarding product/quality system deficiencies and relevant notifications to regulatory authorities. Develop practices, programs and metrics reporting system to ensure optimal efficiency in accordance with FDA regulations, ISO 13485, ISO 14971, 1SO 9001. Show less

    • L&T Technology Services

      Feb 2024 - Mar 2024
      Senior Engineer

      Experience in drafting PSUR documents for medical devices.

  • Licenses & Certifications

    • Excel for Beginners

      Great Learning