شركة متعدد تعلن عن وظيفة أخصائي شؤون تنظيمية وضمان الجودة للأغذية والأدوية (SFDA) في الرياض

Job Title: Regulatory Affairs & Quality Assurance Specialist – Food & Drug (SFDA)

Company: Motaded Limited – Riyadh

Employment Type: Full-time – On-site (Riyadh)

Experience: Minimum 3 years in regulatory affairs and quality assurance within an entity regulated by the Saudi Food and Drug Authority (SFDA).

Role Purpose

To manage all regulatory requirements and compliance files with the Saudi Food and Drug Authority (SFDA) across sectors (food, drug, and cosmetics), and to build and operate the quality management system, standard operating procedures, product tracking, and recall processes — ensuring the company's and its clients' compliance with applicable Saudi regulations.

Key Responsibilities

• Submit and follow up on registration, licensing, and notification applications with the SFDA through its electronic platforms for each sector.
• Develop and implement written Standard Operating Procedures (SOPs) for product tracking, transport, storage, complaints/reports, and safety alert notifications (recall / withdrawal).
• Build, operate, and document the product tracking system (including providing a system screenshot/report on request).
• Prepare and maintain the Quality Management System (QMS) file and review it periodically.
• Monitor SFDA warnings, circulars, and decisions, and update the company's procedures accordingly.
• Manage safety reports and recall cases per SFDA requirements, and coordinate official communication with the Authority.
• Identify the ISO certifications required for each activity and oversee their fulfillment (detailed below).
• Maintain regulatory records and documentation in an organized manner, ready for audit and inspection.

Relevant ISO Standards by Activity

• Food: ISO 22000 (Food Safety Management System, integrating HACCP principles) and FSSC 22000.
• Medical devices (where applicable): SFDA.MD / GSO ISO 13485, or equivalent, as the baseline quality management system for medical device establishment licensing and marketing authorization.
• General quality: ISO 9001 (Quality Management).

Qualifications & Skills

• Bachelor's degree strictly in one of the following: Pharmacy / Pharmaceutical Sciences (drug track), or Food Science & Technology / Food Safety / Food Nutrition (food track).
• Practical knowledge of SFDA regulations, its electronic platforms, and registration/tracking procedures for each sector.
• Experience in developing and implementing written SOPs and quality management systems.
• Fluency in Arabic; English is essential (many SFDA guidelines and ISO standards are in English).
• Accuracy, organization, and the ability to manage multiple regulatory files simultaneously.