Chunnan Chen

A passionate MedTech innovator with a startup mentality, devoted to application and clinical development of novel medical

Chunnan Chen
Aschaffenburg, Deutschland

Erfahrungen

Jan. 2021 - Bis heute
3 Jahren 3 Monaten

Freelance 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 Jahren

Investment 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 Jahren

Special 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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