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Regulatory Affairs Senior Specialist

El Ahlyia Healthcare

من مقر العمل
الموقعCairo, Egypt
نوع الوظيفةدوام كامل
نظام العملمن مقر العمل
الراتبغير محدد
تاريخ النشر

ملخص JobPlatform

نظرة سريعة على الوظيفة

هذه الوظيفة لدى El Ahlyia Healthcare، في Cairo, Egypt، بنظام دوام كامل، ونظام العمل من مقر العمل. تفاصيل الوظيفة والمهارات المعروضة أدناه مأخوذة من إعلان الوظيفة الأصلي.

ملف الشركة

عن الشركة

AIهذا الملخص مُعد بمساعدة الذكاء الاصطناعي اعتمادًا على المعلومات المتاحة، وقد لا يعكس جميع تفاصيل الشركة.

El Ahlyia Healthcare is a healthcare-focused organization seeking qualified professionals to support its operations. The company is currently looking for a Regulatory Affairs Senior Specialist, indicating an interest in navigating regulatory frameworks and ensuring compliance within the healthcare sector. While specific details about the company’s industry, size, or locations are not provided, the job title suggests involvement in areas such as medical device regulation, pharmaceuticals, or health services. The role implies a need for expertise in regulatory processes, documentation, and adherence to legal standards. As a job website, El Ahlyia Healthcare aims to connect skilled professionals with opportunities that align with their experience and career goals. The company’s focus on regulatory affairs highlights its commitment to maintaining high standards in healthcare delivery and compliance.

الوصف الأصلي

عن الوظيفة

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

المسار المهني

نظرة عامة على الدور

AIهذا الملخص مُعد بمساعدة الذكاء الاصطناعي اعتمادًا على المعلومات المتاحة، وقد لا يعكس جميع تفاصيل الشركة.

The Regulatory Affairs Senior Specialist ensures compliance with regulatory standards for medical products. This role involves managing documentation, tracking submissions, and maintaining communication with regulatory bodies.

مصدر الوظيفة

إعلان الوظيفة الأصلي

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