Summary
Overview
Work History
Education
Skills
Certification
Publications
References
Timeline
Generic

Omar Alsohime

Chairman Of Board Of Directors @MEEMPA_Org_Sa, Biomedical Engineer
Riyadh

Summary

- Accredited Small and Medium Enterprises Consultant ASMEC by AASBC: Association of Accredited Small Business Consultants and Monshaat.

- Certified “ Manager Regulatory Affairs Medical Devices International” by TÜV Rheinland & Ulm University for Applied Sciences and experienced as a regulator.

- Member of The Association of German Engineers Membership#12053894.

- Accredited Trainer by Technical and Vocational Training Corporation TVTC.

- Experienced in Medical Devices Supply Chain

- SFDA Medical Devices Marketing Authorization Applications Reviewer

- Master Degree in Biomedical Engineering, Medical Devices Usability & Ergonomics, from Germany.

- Award of the Second Saudi Annual Conference for Quality and Patient Safety (2nd Place for Research Poster).

- Experience in developing guidelines and measuring beneficiaries and stakeholder satisfaction.

- Member of the IEC- Standard Organization Saudi Mirror Technical Committee TC62 for Medical Electrical Equipment.

- Co-Author of the SFDA Requirements of Medical Devices Safe use by Healthcare Facilities.

Overview

16
16
years of professional experience
9
9
years of post-secondary education
5
5
Certifications
1
1
Language

Work History

Board Member

Electrical Engineering Chapter Board In Saudi Council Of Engineers
Riyadh
11.2023 - Current

Setting up and managing the strategy of Electrical Engineering Chapter activities and Practice in the Saudi Arabia which include:


  • Development of Electrical Engineering Professional Standards
  • Enabling Electrical Engineering Chapter
  • Development of specialized training courses and development program for the chapter affiliation
  • Development of Professional Guidelines
  • Raising of technical public awareness about the importance of professional engineering community role & Practice



Medical Equipment Purchase Unit Head

Armament and Supply Deputyship, Ministry of Defence
Riyadh
02.2022 - Current

Implementation of and managing the transformation to the Target Operational Model of Ministry of Defence Medical Supplies.


Development of medical equipment procurement process together with relevant department such as end-users, Hospitals , army and organizations such as NUPCO.


Sourcing Medical Equipment suppliers and medical equipment maintenance service providers.


Sourcing, recruiting & maintaining talents with different capabilities and skill required by department mandate.

Chairman Board of Directors

Medical Electrical Equipment Professionals Association
Riyadh
08.2021 - Current
  • Chaired shareholder meetings, disseminating information and fielded questions.
  • Provided recommendations on board of directors on group's effectiveness, actions and future plans.
  • Led organization in setting goals and strategies.
  • Planned and coordinated large volume and wide variety of meetings, conferences and workshops.

<p>Medical Devices Registration Support Expert</p> <p></p>

Saudi Food & Drug Authority, Medical Devices Sector, Executive Dept. of Scientific Evaluation.  
02.2020

- Preparation & Conducting of Medical Devices monitoring Plan & Identifying Laboratory Test required

- Reviewing and Assessing Medical Devices Marketing Authorization (MDMA) ( GHTF & TFA)

- Supervising and Coordinating Solving of MDMA Applicant issues.

- Conducting Workshops & Training Sessions to educate SFDA applicants regarding Medical Devices Registration Process & Requirements ( GHTF & TFA).

- Conducting Workshops & Training Sessions to educate SFDA employees regarding Medical Devices Registration Process & Requirements( GHTF & TFA).

SME Operation and Processes Consultant

Nawafeth Application
Riyadh
01.2020 - Current
  • Increased customer satisfaction by resolving issues.
  • Participated in continuous improvement by generating suggestions, engaging in problem-solving activities to support teamwork.
  • Actively listened to customers' requests, confirming full understanding before addressing concerns.

<p>Second Specialist Medical Devices Scientific Evaluation & Products Registration Support</p> <p></p>

Saudi Food & Drug Authority, Medical Devices Sector, Executive Dept. of Scientific Evaluation.  
10.2018 - 01.2020

- MDMA (Medical Devices Marketing Authorization) Application Assessor

- Coordination between Medical Devices Lab, Inspectors and Medical Devices Sector Regarding Medical Devices Monitoring Plan

- Conducting Meeting and workshops  With Medical Devices Vendors Regarding Medical Devices Registration 

- Conducting Training for new employees

- Managing Inquiries from Medical Devices Vendors

- Quality Improving of MDMA-applications Reviewing & Communication with vendors

-Secretary of the IEC-TC62D National Committee for Electromedical Equipment Standards



Senior Biomedical Specialist

Saudi Food & Drug Authority, Medical Devices Sector, Standards & Guidelines Department, Guidelines Section.
01.2016 - 10.2018

Acting Section Head of Guidelines Section in case of absence of the Section Head.

Beside the Task (Developing, Updating, and Drafting Medical Devices  Guidelines) there is several achievements:

1- Drafting the Road Map for Saudi Medical Devices Inventor and Technology Transferring.

2-Leading and Closing of ("Arshedni" Platform) Project.

3- Initiative:Redesign of the Guidelines Web pages for better accessibility and usability.

4- Initiative: Creating Continuous Improvement Tools to collect electronically feedback and comments from public.

5- Initiative: Creating the First Standard Awareness Material and conducting Workshop and Presentation for universities and healthcare providers.

6- Initiative: Conducted SFDA-MDS- Lab Gap-Analysis Report for testing the safety of electrical medical devices based on international standards (IEC 60601-1).

7- Lead and Solve Different open problem in the Medical Devices Sector (e.g. Cosmetic Devices, Medical Device Storage, Bundling guidance...).

8- Cooperating with Several Department by offering technical advice regarding medical devices regulations (e.g. Standard, Surveillance..).

Senior Biomedical Specialist

Saudi Food & Drug Authority, Medical Devices Sector, Scientfic Evaluation
06.2015 - 01.2016

Conduct Study on Intensive Pulsed Light (IPL) for Cosmetic Purposes.

Biomedical Specialist

Saudi Food & Drug Authority, Medical Devices Sector, MDMA
08.2009 - 04.2011

Biomedical Engineer

Areomedical Evacuation
01.2009 - 08.2009

Intern Engineer

Several institutions and companies
01.2008 - 01.2009

GE Healthcare Imaging, Neurologica, Sameer Kodak.

Education

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Master of Science in Biomedical Engineering, Muenster University of Applied Sciences, Germany.
10.2012 - 05.2015

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Bachelor of Biomedical Science in Biomedical Technology (Instrument) , King Saud University in Riyadh, Saudi-Arabia
01.2003 - 04.2009

Skills

Teamwork

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Certification

Accredited Small and Medium Enterprises Consultant ASMEC by AASBC: Association of Accredited Small Business Consultants and Monshaat.

Publications

References

  • Regulations & Registration Support Department, Medical Devices Sector Saudi Food and Drug Authority. (Former Manager)

Eng. Abdullah Alguraib


  • Section Manager- Medical Devices Section Manager, Armament and Supply Deputyship. (My Current Manager)

Eng. Hatim Alsaif

  • The Head of the committee of Medical Devices Associated Risk in the German Coalition of Patient Safety (Master Degree Academic Supervisor)

Prof. Dr.-Ing. Uvo M. Hölscher

Timeline

Board Member

Electrical Engineering Chapter Board In Saudi Council Of Engineers
11.2023 - Current

Medical Equipment Purchase Unit Head

Armament and Supply Deputyship, Ministry of Defence
02.2022 - Current

Chairman Board of Directors

Medical Electrical Equipment Professionals Association
08.2021 - Current

Medical Devices Registration Support Expert

Saudi Food & Drug Authority, Medical Devices Sector, Executive Dept. of Scientific Evaluation.  
02.2020

SME Operation and Processes Consultant

Nawafeth Application
01.2020 - Current

Accredited Small and Medium Enterprises Consultant ASMEC by AASBC: Association of Accredited Small Business Consultants and Monshaat.

04-2019

Breakthrough Supply Chain Performance Workshop ( Medical Devices)

04-2019

Second Specialist Medical Devices Scientific Evaluation & Products Registration Support

Saudi Food & Drug Authority, Medical Devices Sector, Executive Dept. of Scientific Evaluation.  
10.2018 - 01.2020

Implementation of SFDA Medical Devices Approval Process ( Technical File Assessments TFAs & Quality Management System QMS) by UL 5 weeks

10-2018

Senior Biomedical Specialist

Saudi Food & Drug Authority, Medical Devices Sector, Standards & Guidelines Department, Guidelines Section.
01.2016 - 10.2018

Senior Biomedical Specialist

Saudi Food & Drug Authority, Medical Devices Sector, Scientfic Evaluation
06.2015 - 01.2016

Certified “ Manager Regulatory Affairs Medical Devices International” by TÜV Rheinland & Ulm University for Applied Sciences

06-2014

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Master of Science in Biomedical Engineering, Muenster University of Applied Sciences, Germany.
10.2012 - 05.2015

Certified ISO 9001:2000-Lead Auditor from BSI Management Systems Malaysia, Sdn Bhd.

10-2009

Biomedical Specialist

Saudi Food & Drug Authority, Medical Devices Sector, MDMA
08.2009 - 04.2011

Biomedical Engineer

Areomedical Evacuation
01.2009 - 08.2009

Intern Engineer

Several institutions and companies
01.2008 - 01.2009

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Bachelor of Biomedical Science in Biomedical Technology (Instrument) , King Saud University in Riyadh, Saudi-Arabia
01.2003 - 04.2009
Omar AlsohimeChairman Of Board Of Directors @MEEMPA_Org_Sa, Biomedical Engineer