Regulatory Affairs Senior Specialist
El Ahlyia Healthcare
Company Description El Ahlyia Healthcare (EHC) is a leading medical supplies distributor that has been serving the Egyptian market since 1995. The company focuses on delivering cutting-edge medical technologies and innovative healthcare solutions to hospitals, clinics, and healthcare providers. EHC has established a strong position in the market and built a solid reputation as a trusted partner in healthcare. The organization is committed to improving people’s lives by ensuring access to high-quality, reliable medical products and services. Joining EHC offers the opportunity to contribute to meaningful work that supports better patient outcomes across Egypt. Role Description The Regulatory Affairs Senior Specialist is a full-time, on-site role based in Cairo, Egypt. This position is responsible for preparing, reviewing, and maintaining regulatory documentation for medical products, ensuring accuracy, completeness, and compliance with local and international regulations. The role includes coordinating and submitting regulatory files and registration dossiers to relevant authorities, tracking approval timelines, and managing renewals and variations. The specialist monitors changes in regulatory requirements, advises internal stakeholders on compliance implications, and supports quality and commercial teams in implementing regulatory policies and procedures. Day-to-day tasks also involve liaising with regulatory bodies, responding to inquiries, supporting audits and inspections, and contributing to continuous improvement of regulatory processes. Qualifications Candidates should possess strong skills in Regulatory Documentation and Regulatory Submissions, including dossier preparation, file compilation, and tracking approvals. Candidates should possess solid expertise in Regulatory Compliance and Regulatory Requirements, with the ability to interpret and apply relevant laws, guidelines, and standards. Candidates should possess foundational knowledge and experience in Regulatory Affairs, covering product registration, post-market changes, and lifecycle management. Bachelor’s degree in Pharmacy, Medicine, Life Sciences, or a related field; an advanced degree or regulatory certification is an advantage. Proven experience in regulatory affairs within medical devices, medical supplies, or pharmaceuticals, preferably in the Egyptian or MENA market. Strong attention to detail, organizational skills, and the ability to manage multiple projects and deadlines. Effective communication skills, with the ability to collaborate with cross-functional teams and interact with regulatory authorities professionally. Proficiency in MS Office and regulatory tracking tools; strong written and spoken English and Arabic skills. Show more
