プロフィール詳細

プロジェクトを作成

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Girish H.に依頼

India

Freelance Medical Writer / Regulatory Expert in Medical Device with 16+ Years of Experience (EUMDR, ISO 13485, FDA510K)

プロフィール概要

An accomplished, versatile, results-oriented clinical research professional with over 16 years of experience in the Pharmaceuticals & Medical Device industries who brings strong leadership to all aspects of clinical Research. Experience includes Medical Writing for both domestic and international markets for the Medical Device and Pharmaceuticals Industry, cross-functional leadership, and outstanding value proposition development and delivery as a leader in organizations of varying size and complexity. Involvement in a number of large and small clinical research projects across multiple therapeutic areas. Mentoring and training are large components of many research projects. Ensuring compliance with the local regulatory, ICH-GCP, MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, EU IVDR 2017/746, ISO- 14155, ISO10993-1, SaMD, NIOSH Submission, SOPs, and any other applicable regulations. Medical Writing Includes (Clinical Evaluation Report (CER), Biological Safety Evaluation, Biocompatibility, IVD PER, Trial Protocol, PMCF, PMS, CIP, ICF, CSR, IB, PSUR, DSUR, PBRER, Manuscripts, Journal Articles, Literatures Systematic Review Analysis, Meta-Analysis and Scientific Documents).

専門分野

• ★ Medical Devices
• ★ European Medical Device Regulation (MDR)
• ★ Clinical Evaluation Reports (CER)
• ☆ Biotechnology & Bioengineering
• ☆ Medical Technologies
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Device Development
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Medical Device Regulatory Consulting
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Medical Device Regulatory Writing
• ☆ Medical Writing
• ☆ Technical & Scientific Writing
• ☆ Project Management
• ☆ Risk Management

サービス

• Writing
• Research
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Data & AI Statistical Analysis

職務経験

Regulatory Quality and Clinical Affairs Consultant

Regulatory Quality and Clinical Affairs Consultant (Freelance)

9月 2022 - 現在

Manager Regulatory Quality and Clinical Affairs

Biotechni SAS.

9月 2020 - 8月 2022

Sr. Manager- Regulatory & Clinical Affairs

Biotech Vision Care Pvt Ltd

1月 2017 - 9月 2020

Regulatory & Clinical Affairs Manager

Meril Lifesciences Pvt Ltd

4月 2011 - 1月 2017

Asst. Manager

BA Research India Ltd

12月 2006 - 4月 2011

学歴

B.Pharmacy

Gujarat University

2月 2002 - 6月 2006

認定資格

• Biocompatibility and Toxicology Risks Assessment of Medical Devices

  TUV SUD

  12月 2025 - 現在

• Lead Auditor Training Programme on Medical Devices QMS ISO 13485

  TUV SUD

  9月 2025 - 現在

• EUMDR 2017/745 Course

  Qmed

  9月 2020 - 現在

• ISO 14155

  Qmed

  9月 2020 - 現在