Chunnan Chen
A passionate MedTech innovator with a startup mentality, devoted to application and clinical development of novel medical
Erfahrungen
Jan. 2021 - Bis heute
3 Jahren 6 MonatenFreelance Consultant
Chen International Consulting
- Medical devices
- Clinical evaluation under EU MDR
- Risk-based biological evaluation
- Post-Market Surveillance System incl. Post-Market Clinical Follow-up
- Product development and clinical & regulatory strategy of novel medical technologies
- Life Sciences & MedTech
- Fundraising incl. research & innovation funding program, from project conceptualization and proposal writing phase to implementation and project exploitation
- Market research; technology evaluation; marketing & sourcing in Taiwan
März 2013 - Dez. 2021
8 Jahren 10 Monaten Aschaffenburg, Deutschland
Clinical Affairs & Clinical Evaluation Manager/ Investorangelegenheiten/ Key Account Manager
emka MEDICAL GmbH
- Joined as co-founding partner of the German start-up MedTech company CGS Sensors in Aschaffenburg (later renamed to emka MEDICAL) in March 2013, with Prokura from then on to November 2020
- Spearheaded clinical application development of innovative medical sensor technologies, based on scientific literature together with intensive brainstorming with KOLs
- Spearheaded fundraising with successful EU and Bavarian fundings secured under MI Medical Innovation & emka MEDICAL respectively
- Spearheaded market research and regulatory strategic planning
- Spearheaded clinical evaluation (acc. MEDDEV 2.7/1 rev 4) & biological evaluation (acc. ISO 10993-1:2018) procedure development and implementation under the EU MDD & MDR
- Participated in R&D of novel and innovative medical technologies
Jan. 2009 - Dez. 2013
4 JahrenInvestment Manager
LAFA LifeTech, Inc.
- Lead technical, clinical & market analysis of MedTech & life science start-up companies, with deals from both the US, China and Taiwan
- Responsible for international business development of two German companies, MHM Harzbecher Medizintechnik GmbH and CGS Sensors GmbH, with the focus in Taiwan and China
- Participated in negotiation of Joint Venture between CGS Sensors GmbH (Germany) and WEGO (Shangdong Weigao Group, China)
- Responsible in co-founding the German start-up MedTech company, CGS Sensors GmbH
- Offered consulting service to the industries for Taiwan government grant funding and participation in European research and innovation projects
Jan. 2008 - Dez. 2009
2 JahrenSpecial Assistant to the President
TaiMed Biologics Inc.
- Participated in establishing R&D pipeline projects of drug development for viral infection diseases
- Successfully licensed anti-H1N1 compounds from Academia Sinica
- R&D project management, and outsourcing contracts
- Participated in planning and establishing the biopharmaceutical research laboratory
- Assisted executive management and leadership in developing and executing strategic government affairs
- Participated in governmental grant fund-raising, including proposal
Jan. 2004 - Dez. 2009
4 Jahren Taiwan, Provinz China
Specialist & Visiting Officer
Industrial Development Bureau (IDB), Ministry of Economic Affairs (MOEA), Taiwan (ROC)
- Governmental outsourced project management at the Food & Pharmaceuticals Sector in the areas of life science, medical devices and food
- Participated in execution and planning of the industrial policy of Taiwan on medical devices & aging-related industries
- Coordinated sector business of the Food & Pharmaceutical Sector
- Participated in MOEA IDB project management of Taiwan's participation in international APEC Life Science Innovation Forum
Jan. 2003 - Dez. 2009
6 Jahren Taiwan, Provinz China
Assistant Project Manager
Medical & Pharmaceutical Industry Technology & Development Center
- Responsible for executing "Project of Healthcare and Medical Devices Industrial Technology Development and Promotion" contracted by the Industrial Development Bureau (IDB), Ministry of Economic Affairs (MOEA), Taiwan
- Responsible in international cooperation
- Approached Taiwanese and foreign medical device companies to facilitate match-making collaboration cases for bilateral industrial cooperation between Taiwan and foreign countries
- Served as the Taiwan contact window at the medical device sector in Industrial Cooperative Conference of Taiwan and the Czech Republic
- Served as Representative for the bilateral cooperation in medical device industries in the 2004 Taiwan Official Industry Delegation to the Czech Republic and Hungary; and in the 2006 Economic Delegation to the Czech Republic, Poland, and Slovakia
- Organizing conferences
- Key member in coordinating international medical devices regulatory seminars and conferences sponsored by Department of Health, Taiwan
- Spearheaded business development to establish collaborations on herbs between herbal companies in the Czech Republic and Poland, and Medical & Pharmaceutical Industry Technology & Development Center
Zusammenfassung
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 in EU, US and Taiwan.
Sprachen
Chinesisch
Verhandlungssicher
Englisch
Verhandlungssicher
Ausbildung
Okt. 1993 - Juni 1997
National Tsing Hua University
B.Sc. · Life Science · Hsinchu, Taiwan, Provinz China
Zertifikate & Bescheinigungen
Certificate of Attendance: How to Maintain a QMS Compliant to MDR & IVDR
Certificate of Attendance: MDR with Brexit: How the Combination is Impacting the European Medical Device Industry
Certificate of Attendance: Risk Management According to EU MDR or ISO
Certificate of Attendance: From Self- Declaration to Certification: Proving Performance Under IVDR
Certificate of Attendance: Addressing the Notified Body Bottleneck
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