Responsible Accountable For
Responsible for registering of medical devices veterinary products and food herbal products with Saudi FDA responsible in Pharmacovigilance issues and directly coordinating with our suppliers as well as responsible for any Adverse Events receive from our suppliers to take the necessary action.
Main Tasks
•Managing of Regulatory Affairs issues whether it is internal and external.
•Responsible for Authorized Representative AR agreements with Company Suppliers to ensure that it is conforming with SFDA requirements.
•Responsible for Medical Device National Registry MDNR listing of medical devices with Saudi FDA.
•Responsible for Medical Device Marketing Authorization MDMA of medical devices with Saudi FDA.
•Responsible for classification herbal products with Saudi FDA.
•Responsible for registration of veterinary products with Saudi FDA.
•Responsible for classification of nonmedical device with Saudi FDA.
•Responsible for Pharmacovigilance issues with Saudi FDA.
•Responsible for Recall of medical devices pharmaceutical items to ensure that it will be complied with SFDA requirements.
•Responsible for Medical Device Import License MDIL with Saudi FDA.
•Responsible for clearances of items requested by the governmental hospitals.
•Tasks to represent Company in different governmental offices.
•Tasks to attend meetings with various suppliers national and international representing Company.
•Prepare various regulatory submissions for product approvalregistration.
•Prepare and submit Saudi FDA applications and respond to Saudi FDA requests for additional information to ensure submission approval.
•Manage Regulatory Affairs employee activities including performance management and recruiting.
•Review governmental rulings to determine changes and probable effects on facility activities.
•Performs other duties and responsibilities as required for smooth and efficient operation.
SkillsEducation Experience
•56 years’ Experience in regulatory
•Bachelor degree in Pharmacy
Communication skills
•Must be able to speak and understand English Arabic
•Must have excellent communication and interpersonal skills
•Must be able to share knowledge and learning
•Must have ability and sense of active learning
•Ability to multitask and work independently in a fastplaced environment
Leadership skills
•Must have proven leadership abilities and lead by example
•Able to accept criticism and deal calmly and effectively within high stress situations
•Must have the ability to create an environment where the Company values are a strong and living reality that embraces the diversity of employees and visitors.
This job is posted in the following Specialties Series 6 MySQL 4 5 Leading By Example FINRA Series 6 FDA
قراءة من المصدر (تنقيب) 
السعودية ▼
اليمن
قطر
الإمارات
الكويت
مصر
البحرين
