QARA Director - Middle East, Africa, Central Asia & Turkey
Medtronic
مجموع سنوات الخبرة :16 years, 9 أشهر
Driving the regulatory operations for Wyeth Nutrition, Nestlé Nutrition and Nestlé Health Science product portfolio in Saudi Arabia.
•Support business growth by aligning compliance strategy with business initiatives
•Strengthen regulatory and compliance culture in the business.
•Building and maintaining trust with the regulators through demonstration of continuous compliance.
•Actively participate in regional trade associations.
•Collaborate with local and global teams to drive pre-market submission.
•Impact assessment of newly introduced regulations on GE Healthcare wide portfolio.
1. Establishment and development of the Compliance assessment Section within the Department.
2. Managing a direct report team of 4 employees to review and evaluate the performance of medical devices establishments and assess their compliance with SFDA requirements and regulations.
3. Investigate medical devices incidents and assess manufacturers’ corrective action plans.
4. An active member of several internal committees within SFDA such as the Committee for Used Medical Devices
1. Establishing and development of the Inspection Section within the department.
2. Establishing procedures for a number of internal processes within the department.
3. Contribute in setting various requirements and regulations.
4. Plan, organize and lead inspection visits to establishments dealing with medical devices.
5. Communicate with companies to resolve conflicts and settle issues.
6. Train new employees and familiarise them with their duties
1. Carry out research and studies on various medical devices.
2. Benchmark and research in relation to different aspects of medical devices regulations worldwide.
3. Update, develop and monitor the Medical Devices Sector page in the SFDA website.
4. Effectively contribute in developing a number of computerized systems such as the “National Center for Medical Devices
5. Contribute in organizing a number of international scientific events related to Medical Devices
Preventive and corrective maintenance for a wide range of medical devices (Lab, OR, research Centre, life support, Ultrasound)
Courses: Cell-material interactions, surface engineering and characterization, biomedical applications of biomaterials, advanced material characterization, biomechanics, spinal biomechanics and instrumentation, biomaterials modelling Dissertation: Investigating surface roughness and surface chemistry influences on osteoblast responses in vitro Awards: "Postgraduate Masters Prize for Bioengineering” awarded by the Department of Mechanical, Material and Manufacturing Engineering for achieving the highest overall mark on the MSc in Bioengineering in 2009