Fawzih AlMASHAMA

Regulatory Affairs Manager with eight years of progressive experience in the Saudi medical-device sector, leading regulatory strategy, product registration, market access, importation compliance and post-market regulatory activities. Proven ability to lead and develop high-performing teams, manage complex multi-manufacturer portfolios, resolve critical shipment and customs issues, and translate SFDA requirements into practical business solutions. Experienced across medical-device lifecycle management, authorized representative responsibilities, regulatory operations and cross-functional stakeholder management.

REGULATORY AFFAIRS MANAGER at Professional Medical Expertise Co. (ProMedEx) (2018 – Present)

• Lead the Regulatory Affairs function and manage a team of 10 professionals supporting a broad portfolio of international medical-device manufacturers.
• Direct Saudi regulatory strategy across new registrations, renewals, certificate updates, product lifecycle changes and market-access activities.
• Delivered 126 MDMA certificates during 2025, comprising 77 new registrations, 28 renewals and 21 certificate updates.
• Managed 131 import-permit applications and resolved 201 shipment cases requiring regulatory intervention, supporting product availability and preventing business disruption.
• Oversaw 844 SFDA documentation and system updates and maintained regulatory data across GHAD, Ragic and internal ERP systems.
• Manage authorized representative agreements, certificate transfers, product additions, manufacturer changes and legal-manufacturer relationships.
• Assess significant and non-significant product changes against applicable SFDA requirements and coordinate authority notifications and certificate updates.
• Provide regulatory support for Customs, FASAH and SABER activities, including urgent clearance cases, import restrictions and shipment-compliance assessments.
• Advise commercial, supply-chain, legal, quality and manufacturer teams on regulatory risks, submission requirements, timelines and practical mitigation plans.
• Built and improved internal workflows, regulatory tracking, team allocation and performance reporting to strengthen compliance and operational visibility.

Bachelor of Science in Biotechnology – University of Sharjah