プロフィール詳細

プロジェクトを作成

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☆☆☆☆☆

VIRAL S.に依頼

India

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

プロフィール概要

  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.

専門分野

• 専門分野の詳細は未入力です。

サービス

• 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

職務経験

Manager Regulatory Affairs

Solco Biomedical Company India Private Limited

3月 2020 - 現在

学歴

M.Sc

Hemchandracharay North Gujarat University

6月 2003 - 6月 2004

認定資格

• RISK ANALYSIS & CLINICAL EVALUATION

  DNVGL

  1月 2021 - 現在