プロフィール詳細

プロジェクトを作成

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Lakshman Prakash B.に依頼

India

experience in Lifesciences in QA, QMS, Regulatory, EU-IVDR, medical device documentation writing clinical trial reports

プロフィール概要

Experience in Lifesciences industry including over 18 years’ experience in QA, QMS, Regulatory, Manufacturing, Quality Unit (Commissioning, Qualification and Validation (CQV), as well as QC, Distribution, coordinating supply chain and production departments, budget preparations in Lifesciences ( Medical Devices such as IVD reagents, kits and equipment and Human vaccines) Facilitated Regulatory and Statutory Compliances of facility for manufacturing of IVD (Molecular Kits, Rapid Tests, Clinical Chemistry Kits, IVD equipment Experienced in cordination with local state and Central regulators for necessary regulatory approvals Experienced and Knowledge of Indian and international GMP regulations, Indian regulations MDR 2017, ISO 13485:2016, Risk management ISO 14971,WHO GMP, GxP guidelines. Qualified s Internal auditor for ISO 13485:2016 and ISO 9001:2015,

専門分野

• ★ European Medical Device Regulation (MDR)
• ★ Risk Management
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)

サービス

• Writing

Writing Technical Writing

職務経験

Head-Qualiaty & Regulatory

RAS Lifesciences Pvt Ltd

10月 2015 - 現在

学歴

M.Sc Biochemistry

Kasturba Medical College, Manipal

6月 1983 - 5月 1986

認定資格

• 認定資格の詳細は未入力です。