General Description: Responsible for regulatory affairs activities to assist in regulatory submission, and monthly reports, and follow the registration status with suppliers and MOH. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards.

• Assist in registering the agencies in the Ministry of Commerce.
• Assist in obtaining and maintaining governmental approval for drugs, medical devices, and related materials.
• Ensure compliance with regulations.
• Collection and submission of MOH invoices.
• Coordinate regulatory documentation activities, studying scientific and legal documents.
•    maintaining familiarity with company product ranges.
• Keeping up to date with changes in regulatory legislation and guidelines.
• Obtaining marketing permissions.
• Identify and interpret relevant regulatory guidelines and outline them to the suppliers.
•   Writing comprehensible, clear emails to the suppliers.

·        preparing documentation and file submissions.

•   Maintain regulatory files. Maintain and update regulatory

authorizations, such as licenses, letters of authorizations, etc. Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, and reports.

• Responding to regulatory authorities' questions within assigned timelines.
•   Support external regulatory agency audits/due diligence questionnaires, providing regulatory input to minimize the potential for findings of non-compliance.

·        Other duties as assigned.

Skills: 

• Excellent written and Verbal communication skills with the ability to listen, articulate and advocate.
• Proactive, high performance, result oriented, and manage projects with ethical integrity.
• Technical system skills (e.g., MS office applications, databases, efficient online research).
• Manage multiple projects and deadlines.