Has the skills to deal with the computer applications.
knowledge and working experience with SFDA in any of the below:
Medical Device Post Market Surveillance and Vigilance
Medical Device Adverse Event Investigation
Managing and Reporting for Medical Devices
EC Medical Devices Vigilance System and Post Marketing Surveillance
Introduction to Regulatory Affairs for Medical Devices
Global Medical Device Regulatory Affairs Professional
Processing of incident notifications, recalls, FSCA and FSN
Introduction to ISO 14971 Risk Management for Medical Devices
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
An Introduction to the Medical Device Regulation
EC Medical Devices Vigilance System and Post Marketing Surveillance
CAPA (Corrective and Preventative Action)
ISO 13485: Quality Management Systems for Medical Devices
Regulatory Requirements and Adverse Event Reporting
Medical Device Regulation
Tasks:
Represent the establishment in governmental institutions.
Liaise with banks, municipality, SFDA any other government departments
Keeping abreast with current labor/ immigration laws and update the HR staff on any changes
Keep the HR team informed of significant problems that may jeopardize the achievement of company goals, and those are not being addressed adequately.
Handle inquires on visa/labor/passport matters etc.
Directs the preparation and maintenance of reports as are necessary to carry out the function of immigration. Prepares periodic reports for management or relevant authorities, as necessary and as required.
Monitors the implementation of an improvement process for all immigration& labour records to be tracked and maintained through the company system.
Directs the preparation and maintenance with respect to visa documentation related to new starters, leavers, transfers and renewals.
Organizes attestation of certificates and legal translation of documents and other activities related to immigration and labour.
Assist in deliveries to the medical supplies when needed.
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