Medical Device Manager

Fudiman Citra

** ***** ******, **** *******, MA, United States 02132|*****.*@*****.***.***|+1-857-***-****

Objective

A full-time Co-op or internship position as regulatory affairs professional in pharmaceuticals or medical device industry. Willing to travel and relocate to other states or countries. Available for full-time from July 2011, and perhaps part-time afterwards.

Education

Northeastern University Boston, MA, United States

Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Devices January, 2013

GPA: 3.75/4

Course enrolled: Introduction to Drug, Biologics and Medical Devices. New Drug Development. Medical Device Development. European Medical Devices Regulations. Managing International Clinical Trials.

Course content: IND, 510(k), NDA, PMA submission, post approval change, international clinical trial planning, regulatory strategy, cGMP, ISO 9000, ISO 13485, Medical Device Directive (MDD)

Nanyang Technological University Singapore

Bachelor of Engineering, Major in Biomedical Engineering, Minor in Entrepreneurship July, 2010

GPA: 4.1/5, upper class honours

Achievement: Academic scholarship from Singapore ministry of foreign affairs

Activities: Inter-school sports committee (2006-2007), OCBC Bank sales representative (2007), welfare school committee (2007-2008), research leader in investment club (2008), business manager in International Games (2008-2009), finance manager in a start-up company “Simple Media” (2008-2009).

Relevant Working Experiences

Nanyang Technological University Singapore

Research Assistant, Final Year Project 2009-2010

• Develop and implement experimental strategy in culturing stem cell and gene therapy

• Monitor, maintain, and control the viability of cell culture

• Report adverse condition of cell culture to supervisor

• Ensure the success of mutant lentivirus (type of HIV virus) infection to the stem cell

• Generate literature report upon the completion of project

Institute of Microelectronics, A*STAR Singapore

Research Assistant, Internship May 2009 – July 2009

• Develop and implement animal tissue testing protocol of a capsule endoscope

• Monitor and record performance of the capsule endoscope on animal tissue

• Design prototype of the capsule endoscope macroscopically using SolidWorks

• Generate literature report upon the end of internship

Additional Working Experiences

KYKObiz Kuala Lumpur, Malaysia

Business Development, Contract February 2010

• Develop business plan for expansion, marketing, and restructuring of KYKObiz

• Organize and lead daily meeting with CEO and staff of KYKObiz

Relevant Skills

Computer skills: 9 years of experience with Microsoft Word, Excel, Power Point, and Adobe Acrobat

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