Work:
ChangZhou TCM Hospital, Department of Cardiovascular - Changzhou, CN
Intern
Asian Community Development Corporation - Boston, MA
Intern
Northeastern University - Boston, MA
Volunteer Guide of Orientation
Education:
Northeastern University - Boston, MA
Master of Science in Regulatory affairs
Northeastern University - Boston, MA
Bachelor of Science in Leadership, GPA 3.85
Skills:
1 year experience as a assistant of clinical trial in Department of Cardiovascular Strong knowledge of medical device regulation for example, 510 (K), IDE, and PMA. Strong knowledge of Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCP), Quality System Regulations (QSR), Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), and ICH guidelines Strong knowledge of FDA regulations and CFDA regulations Solid knowledge of European, Canadian, and Australian Medical device regulations Proficiency in MS Office Applications (Microsoft Word, Excel and PowerPoint) Strong oral and written communication skill Excellent negotiation, and organization skill Verbal and written fluency in Mandarin and English