プロフィール詳細

プロジェクトを作成

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Chunnan C.に依頼

Germany

Passionate MedTech innovator with a startup mentality, devoted to application and clinical development of novel techs

プロフィール概要

An experienced professional with 20 years of industrial experience in MedTech, biopharmaceutical companies and semi-governmental organizations; expertise in corporate operation, governmental affairs, financing, R&D, product development, pre-clinical and clinical evaluation, external research collaborations; familiar with medical device regulations related to marketing products in EU, US and Taiwan.

専門分野

• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Clinical Evaluation Reports (CER)

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Medical Writing, Technical Writing

Research Market Research, Feasibility Study, Technology Scouting, Gap Analysis, Scientific and Technical Research

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Product Evaluation, Concept Development

職務経験

Freelance Consultant

Chen International Consulting

8月 2022 - 現在

Clinical Affairs & Clinical Evaluation Manager/ Investorangelegenheiten/ Key Account Manager

emka MEDICAL GmbH (formerly CGS Sensors GmbH) combined with MI Medical Innovation GmbH

1月 2023 - 1月 2023

Investment manager

LAFA LifeTech, Inc.

7月 2009 - 12月 2012

Special Assistant to the President

TaiMed Biologics Inc.

3月 2008 - 6月 2009

Specialist/ Visiting Officer

Industrial Development Bureau (IDB), Ministry of Economic Affairs (MOEA), Taiwan (ROC)

1月 2005 - 2月 2008

Assistant Project Manager

Medical & Pharmaceutical Industry Technology & Development Center

3月 2003 - 2月 2008

学歴

Life Science, B.Sc.

National Tsing Hua University

8月 1993 - 6月 1997

認定資格

• 認定資格の詳細は未入力です。