Avisek Charan
@avisekcharan
Result-oriented regulatory affairs executive with expertise in medical devices.
What I'm looking for
I am a result-oriented professional with 3 years of experience in the field of Medical Device Safety, specializing in regulatory affairs. My journey has been marked by a commitment to excellence and a proven track record of achieving targets set by clients. I possess excellent interpersonal and analytical skills, which have enabled me to effectively assist in the preparation and submission of technical documentation for CE marking of medical devices.
Throughout my career, I have worked diligently to ensure compliance with international standards, including ISO 14971 and ISO 13485. My role at Vitromed Healthcare has allowed me to prepare submissions for new product applications and conduct thorough literature searches to identify appropriate scientific data for submission packages. I take pride in maintaining accurate regulatory documentation and preparing timely responses to regulatory authorities’ inquiries.
In my previous position at WIPRO, I honed my skills in safety database management and complaint handling, ensuring compliance with FDA regulations and ISO standards. My analytical abilities have been instrumental in evaluating complaint data and collaborating with cross-functional teams to drive product improvements. I am passionate about contributing to the safety and efficacy of medical devices, and I am eager to leverage my expertise in a challenging regulatory affairs role.
Experience
Work history, roles, and key accomplishments
Regulatory Affairs Executive
Vitromed Healthcare
Jan 2024 - Present (1 year 5 months)
As a Regulatory Affairs Executive, I assisted in the preparation and submission of technical documentation for CE marking of medical devices. I ensured compliance with international standards and prepared responses to regulatory authorities' inquiries within assigned timelines.
Regulatory Affairs Executive
Indira Gandhi Institute of Allied Medical Sciences
Sep 2017 - Nov 2023 (6 years 2 months)
During my internship, I reviewed and evaluated regulatory documents to ensure compliance with applicable regulations. I prepared submissions for new product applications and conducted literature searches for scientific data.
Sr. Associate
WIPRO
Apr 2022 - Sep 2023 (1 year 5 months)
As a Sr. Associate in Medical Device Safety, I processed individual case safety reports and ensured compliance with quality system policies. I analyzed complaint data and collaborated with cross-functional teams to improve product safety and quality.
Education
Degrees, certifications, and relevant coursework
Indira Gandhi Institute of Allied Medical Sciences
Bachelor's in Pharmacy, Pharmacy
2017 - 2021
Grade: 8.2 CGPA
Completed a Bachelor's in Pharmacy, focusing on regulatory affairs and compliance with applicable regulations. Reviewed and evaluated regulatory documents, prepared submissions for new product applications, and maintained regulatory documentation.
Midnapore Town School
Higher Secondary, Sciences
2015 - 2017
Grade: 64.8%
Completed higher secondary education with a focus on sciences, achieving a percentage of 64.8%. Developed foundational knowledge in scientific principles and practices.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
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