Regulatory Affairs Officer

Vitateck Medical Equipment Trading LLC

Job Title: Regulatory Affairs Officer

Reporting To: Regulatory Director

Location: Riyadh, Kingdom of Saudi Arabia (KSA)

Job Summary:

The Regulatory Affairs Officer is responsible for ensuring that the company complies with all applicable regulations and guidelines in the Kingdom of Saudi Arabia.

This role involves managing regulatory submissions, maintaining product registrations, and liaising with regulatory authorities such as the Saudi Food and Drug Authority (SFDA).

The officer plays a key role in supporting business continuity by ensuring timely approvals and adherence to local laws.

Key Responsibilities:

• Prepare, submit, and manage regulatory dossiers in compliance with SFDA requirements
• Ensure timely registration and renewal of products, licenses, and permits
• Monitor and interpret Saudi regulations and guidelines, ensuring organizational compliance
• Liaise with regulatory authorities (e.g., SFDA) and maintain strong working relationships
• Review labelling, packaging, and promotional materials for regulatory compliance
• Maintain regulatory documentation and databases
• Support internal teams (quality, supply chain, commercial) on regulatory matters
• Ensure compliance with local pharmacovigilance and reporting requirements (if applicable)
• Participate in audits and inspections by regulatory authorities
• Track regulatory changes and communicate updates to stakeholders