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Regulatory senior specialist
Position Details
Location
Sheraton, Cairo, Egypt Egypt
Posted Date
June 17, 2025
Employment Type
Logistics/Supply Chain
متوسط الراتب
Confidential
Job Description
El-Ahlyia health care for medical supplies -
Company: El-Ahlyia health care for medical supplies –
WebSite: Sheraton, Cairo, Egypt
Job Description:تفضل:
Formulate and implement comprehensive regulatory strategies for both novel and established medical devices, ensuring adherence to applicable local, regional, and international regulations. This includes the preparation and submission of requisite regulatory documentation, such as pre-market notifications, technical files, design dossiers, and applications for CE marking. Furthermore, this role entails the management of product registrations and renewals, as well as the oversight of post-market surveillance reporting. Regulatory guidance will be provided to product development, quality assurance, and marketing teams, and the review and approval of labeling, advertising, and promotional materials will be conducted to ensure regulatory compliance. Finally, this position will support clinical trial teams by securing necessary regulatory approvals and documentation.
Skills:
- At least 3-5 years of experience in regulatory affairs, preferably in the medical device industry.
- Bachelor’s degree in science.
نصائح تهمك
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