The Regulatory Affairs (RA) Specialist is responsible for ensuring that the company’s medical devices are in compliance with all applicable regulations and standards in Saudi Arabia and the wider Middle East region. The RA Specialist will coordinate submission processes, maintain documentation, and liaise with regulatory authorities such as the Saudi Food and Drug Authority (SFDA) to ensure all products are registered, approved, and remain compliant throughout their lifecycle.
Prepare, review, and submit registration dossiers and technical documentation to the SFDA and other relevant authorities.
Monitor and interpret regulatory requirements, guidelines, and standards relevant to medical devices in Saudi Arabia and the GCC region.
Maintain up-to-date knowledge of applicable local and international regulations (e.g., SFDA, ISO 13485, MDR, GHTF).
Coordinate with internal departments (e.g., R&D, Quality, Marketing) to gather and compile the required data for regulatory submissions.
Ensure timely renewal of product registrations and licenses, and oversee post-market surveillance activities as required.
Liaise with regulatory consultants, distributors, and partners to ensure effective market access strategies.
Respond to requests for information or supplementary documentation from regulatory bodies.
Assist in internal and external audits related to regulatory compliance.
Maintain regulatory databases and track submissions, approvals, and renewals.
Provide regulatory compliance training and support to relevant internal teams.
Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
2+ years of experience in regulatory affairs, preferably within the medical device industry.
Familiarity with SFDA regulations and registration procedures for medical devices.
Strong knowledge of global regulatory frameworks (e.g., GCC, EU, US FDA) is an advantage.
Excellent written and verbal communication skills in English; proficiency in Arabic is a plus.
Strong attention to detail, organizational, and project management skills.
Ability to work independently as well as part of a team.
Proficiency in MS Office and regulatory submission tools.
