Profile Details

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USD 100 /hr

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☆☆☆☆☆

Hire VIRAL S.

India

USD 100 /hr

Medical Device Regulatory Consultant. 510k, CE, MDSAP, ISO 13485, 21CFR 820, RISK ANALYSIS, USFDA, MDR 745, UDI

Profile Summary

  Would like to introduce myself as a Leader, pioneer & strategist with over 17 years of rich & insightful experience across diverse industries including Medical Devices and, Pharmaceutical.   Brings with me extensive exposure across a gamut of areas including Project Management, Strategy, Regulatory Affairs, Quality Assurance, USFDA- 510K, CE Mark, Plant Management, Manufacturing / Operational excellence, and having grown from purely shop floor roles to larger accountabilities entailing strategy & leadership in areas of Quality Assurance & Regulatory.   Very well versed with E2E plant management, regulatory & Quality operations functions & developed excellent quality products right from scratch to 510K clearance and CE marking of products with global repute Quality Management System which helped Organizations to complete product registrations in various countries enabling export avenues along with domestic business.   Always champions & harbor’s a culture of “Quality First” commitment & continuous improvement ascendancies, raising the bar daily through unwavering meticulousness and resolve.   Result-oriented decisive leader. I possess multitasking ability to sketch the plan, prioritize the work and manage the complex projects under aggressive timelines.

Subject Matter Expertise

• Expertise details not provided.

Services

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Technical Writing, Copywriting, Newswriting

Research Market Research, Feasibility Study, Gray Literature Search, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Stability/Shelf Life Testing, Product Evaluation, Product Validation, Concept Development

Work Experience

Manager Regulatory Affairs

Solco Biomedical Company India Private Limited

March 2020 - Present

Education

M.Sc

Hemchandracharay North Gujarat University

June 2003 - June 2004

Certifications

• RISK ANALYSIS & CLINICAL EVALUATION

  DNVGL

  January 2021 - Present