Profile Details

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Hire Viqar A.

India

USD 50 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• 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

Work Experience

Head-R&D, RA

Aegis Lifesciences Pvt. Ltd.

March 2019 - January 2021

Sr. Associate- Global Regulatory Services

Freyr Software Solutions

May 2018 - March 2019

Assistant Manager- R&D, RA

Vasmed Technologies Ltd, FZC

August 2015 - March 2018

Executive- R&D, RA

Meril Lifesciences Pvt. Ltd.

September 2012 - June 2015

QA Incharge

Nirmal Quality Products

July 2011 - September 2012

Education

M. Tech (Nanoscience and Technology)

North Maharashtra University

July 2009 - June 2011

B. Pharm

North Maharashtra University

June 2005 - June 2009

Certifications

• Certification details not provided.