Headline

QA/RA || EU MDR || Internal AUDITOR ISO 13485 || Technical Documentation

About

I am currently working as a Medical Device Reporting Analyst with experience in Post Market Surveillance including medical device complaint review, complaint investigation and FDA MDR reporting in regulated environments. With a proficient knowledge of US FDA and EU MDR regulation and as a certified ISO 13485 Lead Auditor I aim to evolve into a quality and regulatory professional in the medical device domain, supporting complaince, regulatory reporting and post market surveillance.

Location

Gurugram

Work experience

Senior Associate at GENPACT, Feb 2024 - Present · 2 yrs 5 mos, India

Business Development Executive at BI Biotech India Pvt. Ltd., Feb 2022 - Jun 2023 · 1 yr 5 mos, Hyderabad, Telangana, India, - Evaluating, Investigating and Resolving customer complaints - Handling SOP for complaint handling - Determining root cause and preventive measures (CAPA Management) - Maintaining customers records , Daily Query Reports and Data Analysis. -

Education

MSc bioinformatics, Bioinformatics, Pondicherry University

Bachelor of Science, Life Sciences, Swami Shukdevanand Mahavidyalaya