Regulatory Affairs & QA Senior Specialist - Saudi National - Riyadh

About This Role

Regulatory Affairs Senior Specialist acts as the liaison between the company and regulatory authorities (SFDA) to ensure that imported products are manufactured and distributed in compliance with appropriate governmental legislation.

Job Responsibilities

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.

Requirements 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).