Regulatory Affairs Officer

Role overview

This is a full-time, in-office opportunity in Jeddah for a Regulatory Affairs Officer. The position focuses on building and maintaining the documentation and regulatory support needed for product registrations, approvals, and continued market compliance across local and international requirements.

What you will do

• Prepare, examine, and keep regulatory records current to support registrations and approvals.
• Manage submissions and coordination with the Saudi Food and Drug Authority (SFDA) and other relevant authorities.
• Track changes in regulations and translate them into practical compliance actions for products and processes.
• Work closely with internal stakeholders and outside partners to move regulatory activities forward.
• Maintain accurate databases, files, and official records related to regulatory affairs.
• Assist with audits and inspections by organizing the required documents and information.
• Guide teams on regulatory expectations for both new launches and existing products.
• Support risk reviews, labeling checks, and improvement initiatives linked to regulatory compliance.

Requirements

Applicants need a strong background in regulatory paperwork and submissions, along with the ability to prepare, review, and organize documentation for authorities. The role also calls for experience communicating by email with external companies, handling MDMA, MDIL, and AR medical licenses through the Ghad platform, and maintaining formal communication with the SFDA to address issues or challenges. A solid grasp of regulatory compliance, applicable laws, standards, and guidelines is essential, as is familiarity with regulatory affairs processes and product lifecycle oversight. A bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field is required. Experience in medical devices or cardiovascular products is preferred, especially with regional and international regulatory frameworks. Strong analytical ability, careful documentation, good organization, and attention to detail are important, along with effective written and spoken English. Arabic is an advantage. The candidate should also be comfortable working with cross-functional teams and managing several deadlines at once.

Additional details

The role is based in Jeddah, Makkah, Saudi Arabia, and is structured as a full-time onsite position.