---
title: "VIBHA V KIDADUMBE - Assistant officer Regulatory Affairs in Bengaluru | Tal"
description: "Meet VIBHA V KIDADUMBE, Regulatory affairs assistant officer | Medical devices | Certified advance clinical research and clinical data management course | QC supervisor Apperentice - stability studies | M.Sc. Chemistry. based in Bengaluru."
image: "https://tal.club/meet/vibha-2/share-image"
---

# VIBHA V KIDADUMBE on Tal

## Headline

Regulatory affairs assistant officer \| Medical devices \| Certified advance clinical research and clinical data management course \| QC supervisor Apperentice \- stability studies \| M\.Sc\. Chemistry\.

## About

I have of hands\-on experience as an Assistant Officer in Regulatory Affairs for medical devices, where I gained strong knowledge of regulatory compliance, documentation, submissions and also certified ISO: 13485\. In addition, I have completed a comprehensive course in Clinical Research and Clinical Data Management, which has equipped me with the skills to understand clinical trial protocols, data handling, and ethical guidelines\. I also bring industry experience from my time as a QC Apprentice, where I gained practical exposure to quality control processes in a leading biopharmaceutical company\. I am now looking to grow further in the regulatory by contributing to impactful projects in the healthcare sector\.

## Location

Bengaluru

## Work experience

Assistant officer Regulatory Affairs at Futura Surgicare Pvt Ltd, Sep 2024 \- Present · 1 yr 11 mos, Bengaluru, Karnataka, India, 1\. Regulatory Compliance o Review and ensure compliance with regulatory requirements for medical devices\. o Prepare and submit regulatory filings, including 510\(k\) submissions, CE marking, CDSCO, MDSAP and other international registrations\. o Monitor regulatory changes and update internal stakeholders on implications for products and processes\. o Conduct Post Market Surveillance, Post Market Clinical Follow up, Risk Management, Periodic Safety Update Report, Manage Product Safety, General Safety and Performance Requirements \(GSPR\), Essential Safety Requirements, Eudamed Registration\. o Obtain test and manufacturing license from CDSCO\. 2\. Quality Assurance Support o Collaborate with Quality Assurance to ensure regulatory requirements are integrated into quality systems\. o Assist in audits and inspections related to regulatory compliance\. 3\. Documentation Management o Maintain and manage regulatory documentation, including regulatory submissions, approvals, and correspondence with regulatory agencies\. o Ensure accuracy, completeness, and timeliness of regulatory submissions and responses\. 4\. Strategic Regulatory Planning o Develop and implement regulatory strategies for new product development and product lifecycle management\. o Provide regulatory guidance to cross\-functional teams on regulatory requirements and timelines\. o Stay updated on industry trends, regulatory changes, and best practices through continuous improvement

Apprentice at Biocon, May 2024 \- Sep 2024 · 5 mos, Bengaluru, Karnataka, India, QC \- Supervisor Apperentice Knowledge on Stability studies Migration of novatech to LIMS knowledge on chemical analysis of API small molecules

## Education

Msc chemistry, Chemistry, Kuvempu University, Shankaraghatta, Shimoga

[View the original profile](https://tal.club/meet/vibha-2)

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