Medical Device Development
Resume:
SHUZHI ZHANG
** ***** ******, ***# *, Malden, MA, U.S.A. 02148
*****.****@*****.***.***
EDUCATION
Northeastern University, Boston, MA April 2012
Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices, GPA: 3.4
Related Courses: New Drug Development, Biologics Development, Medical Device Development
Food, Drug and Medical Device Law, Human Experimentation Methodological
Practice Aspects of Regulatory Compliance, Managing International Clinical Trials
Southern Medical University, Guangzhou, China July 2009
Bachelor of Science in Nursing
Related Courses: Introduction to Nursing, Clinical Trial Development, Drug and Safety,
Activities: Member of the Public Relations Department; Team Volunteer providing educational support to grade school students in low income areas
MAJOR ACADEMIC PROJECTS
Regulatory Plan for Combination Product Spring 2011
• Worked in a team to develop an overall plan from preclinical to post-marketing stage
• Determined the PMOA and submission center.
• Prepared Request for Designation (RFD), pre-clinical plan, clinical plan, CMC, labeling and post-marketing surveillance plans.
• Prepared and delivered presentation to instructors and class
Document Development Spring 2011
• Composed comments to Federal Register for changes to GLPs.
• Prepared SOPs, Manufacturing Batch Records and Deviation Forms for mock drug manufacture process
• Designed the Test Method, QC Record, and Specifications for a mock analytical development process
• Created an informed consent for Phase 2 Clinical Trial.
• Devised an audit checklist, performed a mock audit and prepared audit report for GMP manufacturing area
Research Paper Fall 2010
Studied Chinese Clinical Trials and the related regulations and current problems to author paper The Ethical Challenges and Solutions for Chinese Regulations of Clinical Trials
ACADEMIC EXPERIENCE
Nursing Assistant Internship
Southern Medical University Zhujiang Hospital, Guangzhou, China May 2008-May 2009
• Assisted medicine administration
• Lead group studying of update medical news and nursing methods
• Strengthened communication skills and problem solving capability
VOLUNTEER ACTIVITY
Horizon for Homeless Children, Roxbury, MA Jan. 2010–present
• Corresponded with other volunteers and teachers to set up various activities for the children
• Demonstrated good table manners to the children and led them in exercises to practice these skills
• Read books and helped the children recognize different colors, shapes and sounds
• Taught children how to control the negative emotions, be kind to their friends and share the toys and books with friends
CERTIFICATE
Standard First Aid, CPR-Adult, Infant & Child, AED-Adult March 2011-2013
Conducted by American Red Cross of Massachusetts Bay
SKILLS
Computer: Excel, Word, PowerPoint, Adobe Photoshop, Statistics (SPSS)
Language Fluency: Mandarin, Cantonese, English
Willing to Travel or Relocation: 100 %
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