プロフィール詳細

プロジェクトを作成

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Viqar A.に依頼

India

Medical Device RAQA & NPD Specialist | ISO 13485:2016 Certified Lead Auditor

プロフィール概要

Nanotechnology and Medical Device enthusiast with experience in New Product Development, Regulatory Affairs and Quality Management System. Worked on design and development of advanced products like absorbable stents (Polymer and Magnesium) and drug coated balloon catheters. Experienced in different nanoparticle development and characterization. Skilled in QMS ISO 13485, ISO 14971 and regulatory documentation and global regulatory submissions.

専門分野

• ★ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Regulatory Affairs
• ☆ Risk Management

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing

Research Market Research, Feasibility Study, Fact Checking, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Scientific and Technical Consulting

Product Development Formulation

職務経験

Head-R&D, RA

Aegis Lifesciences Pvt. Ltd.

3月 2019 - 1月 2021

Sr. Associate- Global Regulatory Services

Freyr Software Solutions

5月 2018 - 3月 2019

Assistant Manager- R&D, RA

Vasmed Technologies Ltd, FZC

8月 2015 - 3月 2018

Executive- R&D, RA

Meril Lifesciences Pvt. Ltd.

9月 2012 - 6月 2015

QA Incharge

Nirmal Quality Products

7月 2011 - 9月 2012

学歴

M. Tech (Nanoscience and Technology)

North Maharashtra University

7月 2009 - 6月 2011

B. Pharm

North Maharashtra University

6月 2005 - 6月 2009

認定資格

• 認定資格の詳細は未入力です。