Quality & Regulatory Specialist
On-siteCairo, Cairo, Egypt
Job Summary
Manage product registrations, renewals, variations, and regulatory maintenance activities in Egypt. Prepare, review, submit, and maintain regulatory dossiers and technical documentation while monitoring changes in Egyptian regulatory requirements. Build and maintain strong relationships with regulatory authorities, certification bodies, and other external stakeholders. Ensure product registrations, certificates, declarations, approvals, and technical documentation remain accurate, current, and audit-ready. Maintain and continuously improve SofMedica's Quality Management System (QMS) in accordance with applicable standards and local regulations. Support complaint handling, CAPA activities, supplier qualification, risk management, and continuous improvement initiatives. Prepare the organization for internal and external audits while ensuring ongoing compliance. Provide expert regulatory and quality guidance to support strategic business decisions.
Required Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, Engineering, Quality Management, Regulatory Affairs, or a related field
- Experience with Egyptian medical device regulations and registration processes
- Experience communicating directly with regulatory authorities or certification bodies
- Good understanding of Quality Management Systems
- Experience with documentation control, CAPA, audits, supplier qualification, and complaint handling
- Strong organizational skills and exceptional attention to detail
- High level of integrity, accountability, and professionalism
- Excellent communication and stakeholder management skills
- Passion for continuous improvement and process optimization
- Fluency in Arabic and English
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