Regulatory Affairs & QA Senior Specialist - Saudi National - Riyadh

Overview

I. Regulatory Affairs

• Act as one of the main points of contact for SFDA and be responsible for Imdad's products.
• Report the status of the products and related tasks on a monthly basis.
• Ensure that the equipment is in compliance with SFDA regulations.
• Follow up with logistics for the importation of Imdad's products including Equipment, Accessories and cosmetics.
• Obtain Faseh & Nnjzha approval for logistics to ensure compliant importation of products.
• Ensure approval of product registration applications for equipment, cosmetics, and accessories in KSA.
• Ensure the update of registrations in accordance with relevant legislation, regulations, and guidelines.
• Prepare complete registration dossiers for all products, including reviewing and verifying their compliance with SFDA requirements and regulations.
• Coordinate with suppliers regarding equipment specifications and documentation.
• Review and validate all documents before submission to SFDA.
• Track and ensure that applicable fees are paid on time and all licenses are renewed in a timely manner.
• Support other internal departments with regulatory requests and complaints.
• Monitor updates to SFDA regulations, guidelines, and circulars, assess their impact on company products, and ensure timely implementation of required changes.

II. Quality Assurance

• Ensure that the QMS processes are established, implemented, and maintained.
• Report to the direct manager on how well or poorly the QMS is performing.
• Regularly review the QMS objectives.
• Maintain appropriate records.
• Ensure that all Good Distribution and Storage Practices are applied.

Minimum Qualifications

• Bachelor's degree in biomedical engineering or any related Medical Scientific Field
• Minimum 2 years of experience in Regulatory Affairs

Required Skills

• Excellent communication skills (oral & written), and ability to work well in a team.
• Time Management skills.
• Good computer skills (MS. Office, Excel & Outlook)
• Good knowledge on SFDA Platforms ( Ghad, NnJzha, Faseh ).
• Excellent organization skills.
• Excellent Arabic and English skills (Written & spoken).