Avinash Murugan

R&D Regulatory Affairs Specialist Medical Devices Scientist (GRADE E) Class III Robotic Surgical, Orthopaedic Implants, Pacemakers and Bone Joint Implants | Hexaware Tech |

Role
Regulatory Affairs Specialist at Hexaware Technologies
Location
Chennai, TN, IN
LinkedIn followers
500 followers

About Avinash Murugan

I am an aspiring medical device professional with a confident and buoyant attitude having…

Experience

  1. Regulatory Affairs Specialist

    Hexaware Technologies

    Jan 2025 — Present · Chennai, IN

    Market Access:Leading Research & Development and Registration of Medical devices as a New product development Access Team for International Product Registration of HIP and KNEE Replacement as well as Robotics surgical products (Both Implants and Instruments) including EU and USA.Collection of documents from Multiple Electronic (PLM) Tools such as Enovia, MAP Agile for designing devices and SME from every function for First Time Registration of Implant products.Responsible for Deficiency Requests for the products submitted to the Regulatory Body and Health Ministries of Geographies around the world (Health Authority).Providing response to Deficiency questions by connecting to appropriate SMEs to understand, draft and review the response related to Designing of medical devices.Corporate Project:Preparation and publishing of RA Monthly Highlights.Handled International Change Notification and International Regulatory Notification process to international design and regulatory division.Prepared PPT\'s with Divisional RA Team for International RA Knowledge Center and released it in HEXAWARE LMS portal.

Education

  • SRM University

    Bachelor of Technology (BTech)

    2014 — 2018

  • TOWN HIGHER SECONDARY SCHOOL

    High School Diploma

    2012 — 2014

  • Annamalai University

    Master of Business Administration - MBA

    2020 — 2022

  • TOWN HIGHER SECONDARY SCHOOL

    SECONDARY SCHOOL LEAVING CRTIFICATE

    2000 — 2012

  • SRM University

    Master of Technology - MTech

    2018 — 2020

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Avinash Murugan — Regulatory Affairs Specialist at Hexaware Technologies in Chennai, TN, IN | Unifers