Quality & Regulatory Specialist

About the role

SofMedica Egypt is seeking a detail‑oriented Quality & Regulatory Specialist to establish and maintain a compliant foundation for its operations in the Egyptian market. You will be responsible for managing product registrations, ensuring regulatory compliance, and supporting the Quality Management System.

Key responsibilities

• Manage and coordinate registration, renewal, variation and maintenance of product registrations in Uzbekistan.
• Prepare, review, submit and follow up regulatory dossiers with competent authorities.
• Monitor local regulatory changes and assess their impact on products and operations.
• Maintain communication with regulatory authorities, certification bodies and relevant institutions.
• Ensure product certificates, technical documentation, declarations, approvals and registrations are accurate, valid and properly archived.
• Provide regulatory advice for product launches, imports, distribution, labeling and documentation.
• Manage and maintain the company’s Quality Management System in line with standards, internal procedures and regulatory requirements.
• Document, implement, monitor and continuously improve quality processes.
• Maintain quality records, procedures, work instructions, forms, certificates and technical files for audit readiness.

Required profile

• University degree in Pharmacy, Life Sciences, Engineering, Quality Management, Regulatory Affairs or a related field.
• Previous experience in regulatory affairs, quality assurance, product registration or compliance, preferably in medical devices, pharmaceuticals, healthcare or diagnostics.
• Good understanding of Quality Management Systems.
• Knowledge of Uzbekistan regulatory requirements is a strong advantage.
• Experience with documentation control, complaint handling, CAPA, audits and supplier qualification.
• High integrity, accountability and confidentiality.
• Fluency in Arabic and good command of English.

Required skills

• Proficiency in Microsoft Office.
• Experience with document management tools.