Regulatory Affairs Manager Medical Devices & Pharmaceuticals

About the Role

Fisheye - Executive Search is partnering with a leading healthcare company in Saudi Arabia to recruit a Regulatory Affairs Manager. This full-time position is based in Riyadh and involves managing regulatory affairs across multiple categories, including medical devices, pharmaceuticals, cosmetics, and food & dietary supplements. The role requires a professional capable of overseeing end-to-end SFDA submissions for a diverse product portfolio.

Key Responsibilities

• Prepare 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.

Qualifications and Requirements

• Bachelor's degree in Pharmacy, Life Sciences, Biomedical Engineering, or a related field.
• Over 10 years of regulatory affairs experience in Saudi Arabia.
• Experience must span at least two of the following categories: medical devices, pharmaceuticals, cosmetics, or food & dietary supplements.
• Demonstrated 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.
• Proven track record managing multiple simultaneous submissions and deadlines across various product categories.

Work Environment

This role is a full-time position based in Riyadh, Saudi Arabia, within a leading healthcare company. The Regulatory Affairs Manager will operate in a dynamic environment, managing a diverse product portfolio and ensuring compliance with SFDA regulations.

Application Process

Candidates meeting the specified requirements are encouraged to apply. The salary for this position will be discussed during the interview process.