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Sameer Alhamdan, Senior Biomedical Engineer

Sameer Alhamdan

Senior Biomedical Engineer

Saudi Food & Drug Authority SFDA

Location
Saudi Arabia - Riyadh
Education
Master's degree, English Language during period
Experience
15 years, 0 Months

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Work Experience

Total years of experience :15 years, 0 Months

Senior Biomedical Engineer at Saudi Food & Drug Authority SFDA
  • Saudi Arabia - Riyadh
  • My current job since May 2011

Senior Biomedical Engineer, working in quality and risk dept.

Basic knowledge about standards and government regulations applicable to medical devices outside the Middle East e.g. ISO 13485, 21 CFR 820 QSR,

Experience in related field e.g. Regulatory Affairs, Quality Assurance,

project engineer at EL SIEF DEVELOPMENT COMPANY
  • Saudi Arabia - Riyadh
  • March 2006 to January 2008

Project engineer : my responsibilities include:

• Technical and Financial study of the Tender.
• Negotiation with suppliers for better pricing and terms and conditions.
• Supervising Delivery and Installation of equipment at site.
• Leadership skills
• Ensuring handover of projects before deadline
• Tracking of documentation to ensure collection of invoices from customers.
• Installation of ultrasound machines at different primary healthcare centers all over Saudi Arabia.
• End-user training on ultrasound machines
• Visit to different clients and follow up with them on various issues
• Participating in biomedical maintenance tender, which include arranging of sub-contract's quotation, segregation of specialized equipment and preparation of worksheet for which sub-contract agreement required.

Education

Master's degree, English Language during period
  • at La Trobe university
  • December 2010

• Certificate in English Language during period (February 2008 till December 2008) from La Trobe language centre Melbourne -Australia.

Specialties & Skills

Biomedical Engineering
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Spec Writing
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Biomedical Instrumentation
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Regulatory Affairs
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Instrumentation
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C language
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MAT LAB
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Medical Devices Standards
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Medical Devices Regulations
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مواصفات الأجهزة الطبية
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Languages

Arabic
Expert
English
Expert

Memberships

ISO
  • • Secretary of National mirror of committee of ISO-TC 121 Anaesthetic and respiratory equipment, sin
  • January 2015
GSO
  • • A member of the gulf standards technical committee GSO/TC 11 “Medical Devices and Supplies” since
  • January 2015
CBAHI
  •  Member of Standard Applicability Taskforce Group, Saudi central board for accreditation of healthc
  • March 2018
ISO
  •  A member of ISO-TC 121 Anaesthetic and respiratory equipment
  • February 2014

Training and Certifications

Risk Analysis , Assessment , and Management organized by GSO (Training)
Training Institute:
GSO
Date Attended:
January 2013
Duration:
24 hours
Risk Analysis, Assessment,and Management (Certificate)
Date Attended:
January 2013
Valid Until:
January 2013
3- Understanding an ISO 13485 Quality Management System (Certificate)
Date Attended:
July 2012
Valid Until:
July 2012
Certificate in English Language during period (Certificate)
Date Attended:
February 2008
Valid Until:
December 2008
Understanding FDA’s Medical Device QSR and QSIT (Certificate)
Date Attended:
March 2012
Valid Until:
March 2012
Simplification of work processes and procedures (Certificate)
Date Attended:
July 2011
Valid Until:
July 2011