Implement all activities related to Regulatory Affairs including ensuring that all products provided by the LCS Division are distributed in compliance with appropriate legislation.
Complete regulatory submission forms and file the same along with the necessary accompanying documentation while ensuring maximum efficacy and accuracy.
File submission renewals (in coordination with the Regulatory Affairs Unit Head) to the MOH or related Regulatory Authority, as deemed necessary.
Follow-up with the MOH or related Regulatory Authority regarding the progress of regulatory submissions and inspections, to ensure timely completion of the same.
Attend continuing education courses as often as necessary to keep current on changing RA policies and procedures
Forward all complaints received from the company?s Divisions/ Departments against parties infringing on the company?s rights to the Regulatory Affairs ? Unit Head.
Implement preventive fraud regulations as per MOH regulations and instructions.
Maintain an excellent knowledge of all profile provided by the LCS Division.
Keep up to date with all amendments to the regulatory legislation and guidelines.
Ensure compliance with all MOH regulations and other regulatory authority decrees.
Ensure the companys terms of use are properly published in all sales outlets, on marketing brochures and on websites.
Ensure that all labelling, storage and packing activities related to all medical equipmentdevices are implemented accurately and efficiently in line with the set guidelines.
Ensure that all required documents are up-to-date and adhere to the quality standards required by the Regulatory Authorities to avoid any rejection of our medical equipmentdevices.
Perform ad-hoc and other duties related to the job as assigned by the Direct Manager.
Job RequirementsEducational Qualification?Bachelor Degree in Pharmacy or related medical field.Work Experience?Minimum of 1 year of experience in the same or related field.
