Quality Assurance Medical Device

Wenjing Wang, MS

*** ******** ***. *** ***, Boston, MA 02118. 617-***-****. ****.*****@*****.***.***

(No need for sponsorship)

OBJECTIVE

A second year regulatory affair Master’s degree student with strong scientific knowledge and

research experience seeking full time employment in regulatory sciences.

SKILLS

Computer:

MS-Office Suite, clinical trial database and FDA website exploration, familiarity with AERS

database, DNA sequencing and manipulation software, imaging software, primer design software

Regulatory Affairs:

Technical file writing for CE mark applications, 510(k) & PMA submissions, CAPA, Validation &

Verification, ISO 13485, Design Control & QSR, Quality Assurance & Quality Control, GxP, SOP,

IND, NDA, Drug development, CMC, 21 CFRs, ICH, Informed Consent, etc.

Research:

Protein expression and purification, Cloning, Western blot, DNA and RNA extraction, PCR,

Preparing competent cell, DNA and RNA gel electrophoresis, Protein gel coomassie staining, SDS-

PAGE, DNA sequencing, Mammalian cell transfection and culture, Bacterial transformation and

culture, Rat bone marrow stem cell preparation and differentiation, Small animal surgery, Counting

cells with a haemocytometer, Immunohistochemistry, Light and fluorescence microscopy, FISH,

Mutagenesis, Crossing, Map based cloning

Language:

Native: Chinese Mandarin, fluent in written and spoken English

PROFESSIONAL EXPERIENCE

ViewRay Inc, Mountain View, CA

July 2014 Sep. 2014

Regulatory Affairs/Quality Assurance Co-op

Preparing technical file for CE mark application

• Revised Medical Device Directive (MDD) essential requirement checklist

• Revised the applicable standards for conformity

• Prepared all the needed documents for technical file and uploaded all the documents into

BSI website

• Participated in technical file auditing

• Prepared Documents for Authorized Representative in the EU and uploaded all the

documents

• Ordered CFG (Certificate to Foreign Government) from FDA websites of China, Korea,

Netherlands, Taiwan, and United Arab Emirates

• Helped finishing the Nonconformance (Corrective and Prevention Action) CAPA report

Kansas State University, Manhattan, KS

Sep. 2012 July 2013

Teaching Assistant

Introduction to Organic and Biochemistry

• Taught 15-17 students per semester, explaining appropriate laboratory techniques to

ensure that students abided by laboratory protocols

• Helped students analyze data from their laboratory results

• Graded twenty-two laboratory reports per semester per student

• Proctored both the mid-term and final exams for students to ensure appropriate student

conduct and to act as support if they had any questions

Institute of Biophysics, Chinese Academy of Sciences, Beijing, China

Dec.2010 July 2011

Research Assistant

• Responsible for a research project, worked independently in experimental design, data

analysis and trouble shooting

• Assisted other scientists in expression and purification of recombinant histone variant

proteins

EDUCATION

Northeastern University, Boston, MA March 2015 (expected)

Candidate for Master of Science in Regulatory Affairs (GPA 3.88)

Core courses already taken:

Introduction to Drug and Medical Device Regulation (A)

Human Experimentation (A)

New Drug Development: Regulatory Overview (A)

Medical Devices: Regulatory Overview (A-)

Writing assignment:

FDA meeting request

Pre-IND Meeting Request

Informed Consent

Financial Conflict of Interests

Waiver and Deferral Request

Clinical Development Plan

Kansas State University, Manhattan, KS

Master of Science in Biochemistry August 2013

Chinese Academy of Sciences, Beijing, China

Master of Science in Developmental Biology July 2010

Shan Dong Agriculture University, Tai’an, China

Bachelor of Science in Biotechnology, College of Life Science July 2006

AWARDS

National Scholarship (Shandong Agricultural University): 2002 2005

Awarded for Excellent B.S. Thesis (Shandong Agricultural University): 2006

National Fellowship (Graduate School, Chinese Academy of Sciences): 2006 2007

National Scholarship (Institute of Botany, Chinese Academy of Sciences): 2008 2010

PROFESSIONAL ORGANIZATIONS

Student member of Regulatory Affairs Professionals Society (RAPS)

Member of the American Association for the Advancement of Science (AAAS/Science)

PUBLICATIONS

1. Zhouliang Yu*, Xiang Zhou*, Wenjing Wang, Wenqiang Deng, Junnan Fang, Hao Hu, Zichen

Wang, Shangze Li, Lei Cui, Jing Shen, Linhui Zhai, Shengyi Peng, Jiemin Wong, Shuo Dong,

Zengqiang Yuan, Guangshuo Ou, Xiaodong Zhang, Ping Xu, Jizhong Lou, Na Yang, Ping

Chen, Rui-ming Xu and Guohong Li. Dynamic phosphorylation of CENP-A at Ser68

orchestrates its cell cycle-dependent deposition at centromeres (Accepted by Developmental

Cell)

2. Zhouliang Yu, Zhou Xiang, Wenjing Wang, Wenqiang Deng, Junnan Fang, Hao Hu, Zicheng

Wang, Jiemin Wong, Shuo Dong, Guangshuo Ou, Ruiming Xu and Guohong Li .

The Recognition and Assembly of CENP-A by HJURP during Cell Cycle.

Cold Spring Harbor Asia Conference: Epigenetics, Chromatin & Transcription,

Suzhou, China, April 23 - 27, 2012

3. Wenjing Wang, Ting Liu, Lei Guo, Chun-Ming Liu. SLC/AGO1 coordinates cell division and

expansion in Arabidopsis. Chinese Bulletin of Botany 46 (4),370–378

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