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Profile Details
Contact
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USD 80 /hr
Hire Sneha V.
India
USD 80 /hr

Regulatory Affairs & Quality Assurance Professional | Medical Devices | Internal Auditor | Experienced in US FDA 510(k)

Profile Summary
Subject Matter Expertise
Services
Writing Clinical Trial Documentation, Technical Writing, Copywriting
Research Market Research, Gap Analysis, Gray Literature Search, Systematic Literature Review, Secondary Data Collection
Consulting Regulatory Consulting
Product Development Product Evaluation
Work Experience

Senior Associate - Quality Assurance and Regulatory Affairs

Niramai Health Analytix Pvt. Ltd.

January 2021 - Present

Quality Assurance and Regulatory Affairs Lead

ABM Respiratory Care LLC

September 2018 - July 2020

Biomedical Engineer

Elexes Medical Consulting LLC

February 2018 - September 2018

Education

MTech Biomedical Engineering

Amrita Vishwa Vidyapeetham

June 2015 - July 2017

BE Biomedical Instrumentation Engineering

Avinashilingam University

June 2011 - July 2015

Certifications

  • European Medical Device Regulation

    TUV SUD

    August 2020 - August 2020

  • Internal Auditing for Quality Management System for Medical Devices based on ISO 13485:2016

    TUV SUD

    August 2019 - August 2019