Bader F. Al-Shabrain. MSc, PMP
Director of Regulatory Affairs and Quality at Mediserv KSA- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Mohammed Abid ur Rahman
Bader is known to me since he was working with SFDA Advertising Section as & when we visit as MECOMED representative and as Co representative he was representing SFDA in our meetings. Bader is well mannered humble and professional person. Later on when he joined Mediserv we had to work together with several projects together and we found his abilities which are amazing and his attitude and PR represented Mediserv in a better and professional manner & elevated its approach professionally and to a new level. He proved himself as an asset amazingly worked towards management improvements at Mediserv. He supported by recommending different ways of approach to the resolve certain deadlocks which I believe is his ability to think out of box and approach to resolve issues with a different way helping minimizing issues. I would like to mention apart from so much work as responsibility he took time to improve his knowledge and completed PMP which I believe is proof for his dedication for improvement and professionalism. Wishing him all the success in whatever he is undertaking as next projects. Best Wishes Always. Abid ur Rahman RA Manager Middle East Region Abbott Diagnostics Division
Saad Alghamdi
We’ve worked together on several projects and Bader is one of the best people to have as a partner. I highly recommend him to as a group leader. His ability to add managerial skills helped us during hard times and we were able to innovate Thanks Bader.
Mohammed Abid ur Rahman
Bader is known to me since he was working with SFDA Advertising Section as & when we visit as MECOMED representative and as Co representative he was representing SFDA in our meetings. Bader is well mannered humble and professional person. Later on when he joined Mediserv we had to work together with several projects together and we found his abilities which are amazing and his attitude and PR represented Mediserv in a better and professional manner & elevated its approach professionally and to a new level. He proved himself as an asset amazingly worked towards management improvements at Mediserv. He supported by recommending different ways of approach to the resolve certain deadlocks which I believe is his ability to think out of box and approach to resolve issues with a different way helping minimizing issues. I would like to mention apart from so much work as responsibility he took time to improve his knowledge and completed PMP which I believe is proof for his dedication for improvement and professionalism. Wishing him all the success in whatever he is undertaking as next projects. Best Wishes Always. Abid ur Rahman RA Manager Middle East Region Abbott Diagnostics Division
Saad Alghamdi
We’ve worked together on several projects and Bader is one of the best people to have as a partner. I highly recommend him to as a group leader. His ability to add managerial skills helped us during hard times and we were able to innovate Thanks Bader.
Mohammed Abid ur Rahman
Bader is known to me since he was working with SFDA Advertising Section as & when we visit as MECOMED representative and as Co representative he was representing SFDA in our meetings. Bader is well mannered humble and professional person. Later on when he joined Mediserv we had to work together with several projects together and we found his abilities which are amazing and his attitude and PR represented Mediserv in a better and professional manner & elevated its approach professionally and to a new level. He proved himself as an asset amazingly worked towards management improvements at Mediserv. He supported by recommending different ways of approach to the resolve certain deadlocks which I believe is his ability to think out of box and approach to resolve issues with a different way helping minimizing issues. I would like to mention apart from so much work as responsibility he took time to improve his knowledge and completed PMP which I believe is proof for his dedication for improvement and professionalism. Wishing him all the success in whatever he is undertaking as next projects. Best Wishes Always. Abid ur Rahman RA Manager Middle East Region Abbott Diagnostics Division
Saad Alghamdi
We’ve worked together on several projects and Bader is one of the best people to have as a partner. I highly recommend him to as a group leader. His ability to add managerial skills helped us during hard times and we were able to innovate Thanks Bader.
Mohammed Abid ur Rahman
Bader is known to me since he was working with SFDA Advertising Section as & when we visit as MECOMED representative and as Co representative he was representing SFDA in our meetings. Bader is well mannered humble and professional person. Later on when he joined Mediserv we had to work together with several projects together and we found his abilities which are amazing and his attitude and PR represented Mediserv in a better and professional manner & elevated its approach professionally and to a new level. He proved himself as an asset amazingly worked towards management improvements at Mediserv. He supported by recommending different ways of approach to the resolve certain deadlocks which I believe is his ability to think out of box and approach to resolve issues with a different way helping minimizing issues. I would like to mention apart from so much work as responsibility he took time to improve his knowledge and completed PMP which I believe is proof for his dedication for improvement and professionalism. Wishing him all the success in whatever he is undertaking as next projects. Best Wishes Always. Abid ur Rahman RA Manager Middle East Region Abbott Diagnostics Division
Saad Alghamdi
We’ve worked together on several projects and Bader is one of the best people to have as a partner. I highly recommend him to as a group leader. His ability to add managerial skills helped us during hard times and we were able to innovate Thanks Bader.
Credentials
-
PMI Agile Certified Practitioner (PMI-ACP)
Project Management InstituteSep, 2020- Sep, 2024
Experience
-
-
Director of Regulatory Affairs and Quality
-
Jan 2021 - Present
• Leading and managing governmental affairs duties and that includes (Saudi FDA, Ministry of Commerce, Ministry of Investment, MOI, Customs, NUPCO & MoH) • Leading Regulatory Affairs, Quality Management, Custom Clearance & Compliance Department • Managing relation with governmental Agencies (SASO, SFDA, MOI, MCI and Saudi Customs) • Provide department’s strategic planning to the company’s board of directors. • Preparation and Approval of annual budgets • Team management, coaching and report annual performance evaluation to achieve entity’s objective These tasks are performed for several stakeholder some of which are International Leaders in Healthcare sector (Pharmaceuticals & Medical Devices) Show less
-
-
-
-
Regulatory Affairs and Quality Manger
-
Jul 2018 - Present
• Managing Regulatory & Compliance teams and supervising daily operations. • Managing external communications and company representation to competent authorities. • Execute strategies for Saudi FDA pre-market requests submission. • Customer consultations on Saudi FDA regulation requirement. • Provide weekly KPI report to direct management. • Perform internal audits to ensure QMS is valid and maintained • Managing Regulatory & Compliance teams and supervising daily operations. • Managing external communications and company representation to competent authorities. • Execute strategies for Saudi FDA pre-market requests submission. • Customer consultations on Saudi FDA regulation requirement. • Provide weekly KPI report to direct management. • Perform internal audits to ensure QMS is valid and maintained
-
-
-
-
Head of Advertising section
-
Feb 2009 - Jul 2018
- Participation with MDMA department in the technical reviewing of all applications on MDMA system for all classifications and audit certificates and documents of medical devices products.- Implementation of advertising section - The owner of medical device advertisement project. - Review of orders submitted by companies to advertise or request permission technical lectures . - ---- Participate in some standards committee
-
-
Laboratory Specialist
-
Feb 2009 - Feb 2013
- Performed benchmarking study on the regulation of IVD medical devices- Participated in inspecting IVD shipments at port of entries .- Good knowledge in international certificates ( CE & FDA ) .- Good knowledge in reviewing product certificates presented for import permits .- Member in classification committee .- Good knowledge in writing (SOPs).
-
-
-
King Fahad Medical City
-
Saudi Arabia
-
Hospitals and Health Care
-
700 & Above Employee
-
Medical Technologist
-
Feb 2005 - Feb 2009
- Gel station machine - Hematos system - Performs routine: Blood grouping, antibody screening & identification and cross-matching, investigation of transfusion reactions. - Coordinator for blood donation campaign - Gel station machine - Hematos system - Performs routine: Blood grouping, antibody screening & identification and cross-matching, investigation of transfusion reactions. - Coordinator for blood donation campaign
-
-
Education
-
2012 - 2015
King Saud University
Master's degree, Hospital and Health Care Facilities Administration/Management -
1997 - 2004
King Saud University
Bachelor's degree, Clinical Laboratory Science/Medical Technology/Technologist
Community
