Medical Device Engineering

Guangshen Yu

Street: ** ********* ******, *** ***, Malden, MA, 02148

Phone Number: 617-***-****

Email: **.**@*****.***.***

Education Background

Northeastern University, Boston, MA Sep. 2012-Mar. 2014

Master’s Degree of Regulatory Affairs for Biologics, Drugs, and Medical Devices

Courses: Introduction to Drug and Medical Device Regulation; Human Experimentation: Methodological Issues

Fundamentals; Medical Device Developmen; Biologics Development; New Drug Development;

European Medical Device Regulations; Food, Drug, and Medical Device Law; Biomedical Product

Development: From Biotech to Boardroom to Market; Project Management in Early Drug Discovery

and Development; Drug and Device Supplier Risk Management: Compliance and Processes

Shandong Agriculture University, Taian, China Sep. 2007-May. 2011

Bachelor’s Degree of Biotechnology

Courses: Biochemistry, Organic and Inorganic Chemistry, Zoology, Botany, Microbiology, Genetic Engineering,

Molecular Immunity and Molecular Biology, Biomedical Engineering

Academic Experience

Shandong Agriculture University, Taian, China

Study about Breeding Wheat Cultivars With High Quality Sep. 2009-Sep. 2010

Directed by Professor Li Sishen

Successfully use technology of cross-breeding to breed lodging resistance and high quality wheat

Study about the Germplasm Resources of the Wheat Sep. 2009-Sep. 2010

Directed by Professor Li Sishen

Through the method of biostatistics to analyze various characteristics of the advanced varieties

Qingdao Agriculture University & Ocean University of China, Qingdao, China

Study about Selecting Algae with High Rate of Producing Bio-oil Sep. 2010-Mar. 2011

Directed by Professor Yi Yanjun

Apply the method of biostatistics to analyze 16 kinds of Algae which has the ability to produce bio-oi from

comparing and contrasting their biological characteristics to get valuable gene sequence.

Leadership Experience

Shandong Agriculture University, Taian, China

Assistant of Commission for Discipline Inspection Sep. 2007-May. 2008

Monitor of Class 3 of the Biotechnology in College of Life Science Sep. 2007-May. 2009

Skills

Language: Fluent in Mandarin Chinese, Experience in English-Chinese Translation

Computer: Proficient in Microsoft Office Suite; Extensive Internet Research Skills

Biotechnology Professional: Familiar with the Experimental Apparatus; Fluent in Conducting the

Scientific Experiments; Familiar with mechanisms of Biotech experiment

Regulatory Affairs Professional: Familiar with the Approval Process of Biologics (BLA), Drugs (NDA), and

Medical Devices (510K and PMA); Acquainted with eCTD format; Know well

about the FDA’s Food and Drug Law and Regulation, and ICH guidance.

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