Chunnan Chen
Freelance Consultant
Experience
Freelance Consultant
Chen International Consulting
- Clinical evaluation under EU MDR
- Risk-based biological evaluation
- Post-market surveillance system including post-market clinical follow-up
- Product development and clinical & regulatory strategy of novel medical technologies
Clinical Affairs & Clinical Evaluation Manager / Key Account Manager
emka MEDICAL GmbH
- Joined as co-founding partner of the German start-up MedTech company CGS Sensors (later renamed emka MEDICAL)
- Spearheaded clinical application development of innovative medical sensor technologies based on scientific literature and intensive brainstorming with KOLs
- Led fundraising with successful EU and Bavarian funding secured under MI Medical Innovation & emka MEDICAL
- Directed market research and regulatory strategic planning
- Developed and implemented clinical evaluation (per MEDDEV 2.7/1 rev 4) & biological evaluation (per ISO 10993-1:2018) procedures under EU MDD & MDR
- Participated in R&D of novel and innovative medical technologies
Investment Manager
LAFA LifeTech, Inc.
- Led technical, clinical and market analysis of MedTech & life science start-up companies with deals in the US, China and Taiwan
- Managed international business development for German companies MHM Harzbecher Medizintechnik GmbH and CGS Sensors GmbH with a focus on Taiwan and China
- Participated in negotiation of a joint venture between CGS Sensors GmbH (Germany) and WEGO (Shangdong Weigao Group, China)
- Co-founded the German start-up MedTech company CGS Sensors GmbH
- Provided consulting services for Taiwan government grant funding and participation in European research and innovation projects
Special Assistant to the President
TaiMed Biologics Inc.
- Participated in establishing R&D pipeline projects for drug market development in viral infection diseases
- Successfully licensed anti-H1N1 compounds from Academia Sinica
- Managed R&D projects and outsourcing contracts
- Helped plan and establish a custom biopharmaceutical research laboratory
- Assisted executive management in developing and executing strategic government affairs
- Participated in governmental grant fund-raising proposals
Specialist & Visiting Officer
Industrial Development Bureau, Ministry of Economic Affairs (MOEA), Taiwan
- Managed outsourced government projects at the Food & Pharmaceuticals Sector in life science, medical devices and food areas
- Participated in execution and planning of Taiwan’s industrial policy on medical devices & aging-related industries
- Coordinated sector business of the Food & Pharmaceutical Sector
- Participated in MOEA IDB project management of Taiwan's APEC Life Science Innovation Forum
- Served as the Taiwan contact window at Industrial Cooperative Conferences
- Served as representative for bilateral cooperation in medical device industries in official delegations to Europe
- Organized conferences
- Coordinated international medical devices regulatory seminars and conferences sponsored by the Department of Health, Taiwan
Assistant Project Manager
Medical & Pharmaceutical Industry Technology & Development Center
- Executed the Project of Healthcare and Medical Devices Industrial Technology Development and Promotion contracted by MOEA IDB
- Managed international cooperation
- Approached Taiwanese and foreign medical device companies to facilitate match-making collaboration for bilateral industrial cooperation
- Served as the Taiwan contact window at industrial cooperative conferences
- Served as representative for bilateral cooperation in medical device industries in official delegations to European countries
- Organized conferences
- Coordinated international medical devices regulatory seminars and conferences
- Spearheaded business development to establish collaborations between herbal companies in Czech Republic, Poland and Medical & Pharmaceutical Industry Technology & Development Center
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Healthcare (20.5 years), Biotechnology (8 years), Pharmaceutical (7 years), and Food and Beverage (4 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Research and Development (13.5 years), Quality Assurance (12 years), Strategy (10 years), Sales (7.5 years), Project Management (7 years), and Product Development (6 years).
Summary
An experienced professional with more than 19 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.
Skills
Medical Technology Research & Application Development
Medical Device Development Strategy
Regulatory Strategy
Risk Management
Clinical Affairs & Clinical Evaluation Planning And Reporting
Biological Evaluation Planning And Reporting
Post-market Surveillance System, Incl. Post-market Clinical Follow-up
Investment Evaluation
Fundraising, Incl. Eu Research & Innovation Funding Program Esp. For Sme
Business Development
Eu Mdd 93/42/eec
Eu Mdr 2017/745
Mdcg, Meddev, Nbog, Etc., Esp. Meddev 2.7/1 Rev. 4
Iso 10993
Iso 13485
Iso 14971, Iso/tr 24971
Iso/tr 20416
Languages
Education
National Tsing Hua University
B.Sc. · Life Science · Hsinchu, Taiwan, Province of China
Profile
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