Regulatory Affairs Manager – Medical Devices & Pharmaceuticals

Fisheye Executive Search is partnering with a leading healthcare company in Saudi Arabia to hire a Regulatory Affairs Manager. This is a multi-category regulatory role spanning medical devices, pharmaceuticals, cosmetics, and food & dietary supplements — ideal for a regulatory professional comfortable owning end-to-end SFDA submissions across a diverse product portfolio.Key ResponsibilitiesPrepare and maintain complete regulatory technical files for medical devices in compliance with ISO 13485, including Risk Management Reports (RMR), Post-Market Surveillance reports/PSUR, and Clinical Evaluation Reports (CER).Coordinate medical device registration and listing submissions through the Saudi Food and Drug Authority (SFDA) systems, tracking status and responding to queries.Manage pharmaceutical drug registration dossiers in accordance with SFDA requirements, including compiling and reviewing CTD modules, and handling variations and renewals.Respond to SFDA deficiency letters and regulatory queries across all categories, ensuring timely and complete resolution.Oversee regulatory compliance for cosmetics products, including product listing, registration, variations, and renewals.Manage food & dietary supplement regulatory activities, including product listing, registration, and ongoing compliance with SFDA requirements.Maintain a regulatory tracking system/calendar across all product categories to ensure no registration, renewal, or reporting deadline is missed.What We're Looking For10+ years of regulatory affairs experience in Saudi Arabia, spanning at least two of: medical devices, pharmaceuticals, cosmetics, or food & dietary supplements.Deep, hands-on experience with ISO 13485 technical file preparation and SFDA's device and/or drug registration systems.Strong working knowledge of CTD dossier structure and drug variation/renewal processes.Track record managing multiple simultaneous submissions and deadlines across product categories.Bachelor's degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field.Fluent in Arabic and English.