プロフィール詳細

プロジェクトを作成

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Sneha V.に依頼

India

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

プロフィール概要

A dedicated Regulatory Affairs and Quality Assurance professional (Medical Devices) having 3.4 years of experience in US FDA, EU MDD, and ISO 13485:2016 QMS, UDI, CER requirements, and submissions. Served as the Management Representative and primary regulatory point of contact in the global regulatory market. Completed and submitted a few design dossiers in the US and EU markets. A trained Internal Auditor for ISO 13485:2016 having participated and cleared many internal, external and market clearance audits. Involved and interacted with the product development team at all stages to maintain and improve product compliance and quality.

専門分野

• ★ Quality Assurance & Quality Control (QA/QC)
• ★ Product Compliance
• ★ Medical Writing

サービス

• Writing
• Research
• Consulting
• Product Development

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

職務経験

Senior Associate - Quality Assurance and Regulatory Affairs

Niramai Health Analytix Pvt. Ltd.

1月 2021 - 現在

Quality Assurance and Regulatory Affairs Lead

ABM Respiratory Care LLC

9月 2018 - 7月 2020

Biomedical Engineer

Elexes Medical Consulting LLC

2月 2018 - 9月 2018

学歴

MTech Biomedical Engineering

Amrita Vishwa Vidyapeetham

6月 2015 - 7月 2017

BE Biomedical Instrumentation Engineering

Avinashilingam University

6月 2011 - 7月 2015

認定資格

• European Medical Device Regulation

  TUV SUD

  8月 2020 - 8月 2020

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

  TUV SUD

  8月 2019 - 8月 2019