Regulatory Affairs Officer

Job Summary:

We are seeking a Regulatory Affairs and QA Officer to support regulatory submissions, ensure compliance with SFDA regulations, and maintain quality standards for medical devices and IVD products. The role requires coordination with manufacturers and internal teams to ensure timely product registration and regulatory compliance. The vacancy will offshore based in favor of Samir Group - KSA

Key Responsibilities:

• Support SFDA regulatory submissions (including MDMA applications).
• Prepare, review, and update regulatory documentation.
• Assist in product classification according to SFDA requirements.
• Monitor SFDA regulatory updates and communicate required actions internally.
• Maintain and update RA & Quality databases and documentation.
• Ensure compliance with internal quality procedures.
• Coordinate with manufacturers and cross-functional teams.
  
  

Requirements:

• Bachelor’s degree in Quality Management or related field.
• 3–5 years of experience in Regulatory Affairs in the medical field is a must.
• Knowledge of SFDA regulations for medical devices and IVD is preferred.
• Internal audit certification is a plus.
• Strong proficiency in MS Office (Outlook, Word, Excel).
• Advanced English (writing: must, speaking: preferred).