Thulasingaraja Baskar

ISO 13485:2016 Lead Auditor | Specialist -Regulatory Affairs | Design Control | Medical Device QARA | New Product Development & Sustenance Engineering | Design Verification & Validation | EU MDR 745/2017| US FDA

Role
Specialist- Regulatory Affairs at Tata Elxsi
Location
Chennai, TN, IN
LinkedIn followers
500 followers
General Business & ManagementView LinkedIn profile

Experience

  1. Specialist- Regulatory Affairs

    Tata Elxsi

    Dec 2023 — Present · Pune, IN

    Standard Gap Assessment, DHF Gap Assessment and Remediation- Risk documents, Design Control documents including Design Verification and Validation documents, Sterilization, Packaging and Cleaning validation documents for Class IIb Implantable medical devices

Education

  • Vel Tech Multi Tech Dr. Rangarajan Dr. Sakunthala Engineering College

    Bachelor of Engineering - BE

    2009 — 2013

  • St. Peter's Institute of Higher Education and Research

    Master of Engineering - MEng

    2017 — 2019

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Thulasingaraja Baskar — Specialist- Regulatory Affairs at Tata Elxsi in Chennai, TN, IN | Unifers