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Medical Device Quality Assurance

Location:
Houston, Texas, 77089, United States
Salary:
$50,000-$60,000
Posted:
June 06, 2012
Email:
mzfzrf@r.postjobfree.com
Contact Info:
*********@*****.***


LOI NGOC NGUYEN M.Sc, B.Sc, RRT,CPFT

***** **** ******** **
Houston, TX 77089
Tel : 281-***-****
Cell: 281-***-****
E-mail: mzfzrf@r.postjobfree.com

CAREER OBJECTIVE:

To obtain a position in Regulatory Affair Profession in order to develop essential skills and gain experiences in the areas of Regulatory Affairs and Quality Assurance of drugs, biologics and medical devices.

EDUCATION:

Master of Science in Regulatory Affair 04/2012, College of Professional Study-Northeastern University-Boston Massachusetts- USA. Cumulative GPA: 3.57

Relevant coursework: Drug and Medical Device Regulations; New Drug Development; Biologics Development; Medical Device Development; Human Experimentation; Food, Drug and Medical Device Laws; Japan Medical Device Regulations & Registration; The FDA: Creation, Behavior and Regulatory; Regulations of Generic and Biosimilar Products; Advertising and Promotion of Drugs and Medical Devices.

Bachelor of Science-Respiratory Care; 08/15/2008; University of Texas medical Branch (UTMB)-Galveston, Texas – USA. Cumulative GPA: 3.48

Associate Applied Science-Respiratory Care, May 2006, San Jacinto College-Texas- USA Cumulative GPA: 3.72

Doctor of Dentistry, 1992 , Medical & Medicine University in Ho Chi Minh City-Viet Nam.
Bachelor of Art- Business Administration -Tourist and Hospitality Management-,1997, Tourist Faculty of Ha Noi Open University.-Viet Nam

Credentials:

• NBRC’s RRT Credential; Registry #:95474
• NBRC’s CPFT Credential; Registry #:95474
• Texas’ RCP licensure , License number: 18401,
• Certificates of BLS, ACLS and PALS issued by American Heart Association.
• Active member of The Regulatory Affairs Professional Society ( RAPS)
• Active member of The American Association of Respiratory Care (AARC)

HONORS:
• UTMB’s Academic Scholarship Award Fall 2007-2008.
• Dean's Honor List, San Jacinto College-Central , 6 consecutive semesters 2003 to 2006
• The National Dean's Honor List of the year 2005.
• Lubrizol Scholarship and Recognition Award of 2005
• Phi Theta Kappa Active Member since 2004
EXPERIENCES AND SKILLS:
1. Regulatory:
• Knowledge of clinical trial clinical site management and monitoring, Informed Consent Document, Investigator’s Brochure and other trial related documents, IRBs, sponsor and investor obligations and other regulations related to human subject protection.
• Knowledge of various regulatory activities like dossier filing and submission , technical documents like CTDs and eCTDs
• Knowledge of key regulatory submissions like IND,NDA/BLA, IDE, 510(k), PMA, HDE,
• Knowledge of US regulations for Drugs, Biologics and Medical Devices, Overview of Japan Medical Devices regulations and submission.
• Knowledge of US FDA’s regulations on Post-Approval requirements, Reporting, Labeling and Advertising/Promotion, off label promotion, generics and biosimilar products
• Ability to assume multitask and pay attention to details
• Ability to function well as a member of the team and build relationship between Regulatory Affairs department and other areas of the organization
• Ability to learn and stay abreast of regulations pertinent to food, drug, biologic, and medical device.
• Computer proficiency in Microsoft Office: MS Word, Excel, and PowerPoint. Ability to manage tiny nuances of data in a multigigabyte documents that are thousands of page long
• Experience working with diverse cultures and cross functional team.
• Experience working with technical documentation.
• Experience with project management and adherence to time schedules.
• Excellent English in speaking, reading and demonstrated strong writing/technical writing skills
2. Respiratory: Almost six (6) year experiences in performing all tasks and duties of a Registered Respiratory Therapist (RRT) in hospital setting such as patient assessment, deliver and monitor respiratory care treatments and interventions, education patient and family for asthma and COPD management , home care and pulmonary rehabilitation and so forth.
3. Sales & marketing pharmaceutical products: Almost ten (10) year experiences in pharmaceutical industry demonstrated the leadership in sales & marketing activities .
• Establish the sales and distribution network for GlaxoWelcome and Tridem Pharma in the South of VietNam,
• Co-ordinate with Regulatory Affair Department to collect data of the clinical trials , support the preparation and submission of the dossiers to the Vietnamese Ministry of Health ( VietNam MOH)
• Recruit and train the sales force staffs as Medical Representative.
• Known by Chief Representative of GlaxoWelcome Viet Nam as “Innovative, dynamic, dedicated, and dependable employee“.

WORK HISTORY:

* 04/2009 until now:Respiratory Therapist, Kindred Rehabilitation Hospital at Clear Lake, Houston TX.
* 11/2008 – 04/2009: Respiratory Therapist, Triumph Health Care at Clear Lake Houston TX.
* 08/2007 - 08/2008: Respiratory Therapist, University of Texas Medical Branch-UTMB, John
Sealy Hospital, Galveston Texas
* 10/2006- 04/2007: Respiratory Therapist in San Jacinto Methodist Hospital- Baytown, Houston, Texas.
* 12/1999 to 10/2002: Marketing Manager of Tridem Pharma Rep. Office in Viet Nam
* 1998 to 11/1999: Sales Manager of Alcon Representative Office in Viet Nam
* 1992 to 1998: District Manager of GlaxoWellcome Representative Office in Viet Nam

COMMUNITY SERVICE / FAMILY
• Community Service Society in HCMC-Viet Nam to help poverty and disaster people.
• San Jacinto College’s Out of School Program: Tutoring the elementary students in Clear Lake areas.
• Volunteer in Adult Acute Elderly ( ACE) Unit-UTMB’s John Sealy Hospital to help senior patients especially oncology patients while they’re staying in ACE unit/10 floor

REFERENCES

1. Ronald Mlcak PhD., RRT, FAARC
Director Cardiopulmonary Department
Shriners Hospital for Children in Galveston
815 Market Street
Galveston, TX 77550-2725
Office: (409) ***-****
Cell: (409) ***-****
Email: mzfzrf@r.postjobfree.com

2. Fatma Ali
Director of Regulatory Affairs & Quality Assurance
Millar-Instruments, Inc.,
6001-A Gulf Freeway
Houston, Texas 77023
Phone: 832-***-****
Email: mzfzrf@r.postjobfree.com

3. Dr. Phyllis J Rundhaug.
Prof. of Psychology
G. C. Mc Collum Administration
8060 Spencer Highway, Pasadena, TX 77505
Office: 281-******* Ext. 1771
mzfzrf@r.postjobfree.com

4. Mr. Larry Vandiver, RRT
Department Chair of Respiratory Department
San Jacinto College-Central
8060 Spencer Highway, Pasadena, TX 77505
Office: 281-******* Ext. 1864