Abrar Admin

POS Enterprise

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 Job Title:
 
 Regulatory Affairs Specialist
 
 
 
 Company:
 
 POS Enterprise
 
 
 
 Location:
 
 Egypt (with flexibility to travel internationally)
 
 
 
 Job Summary:
 
 
 
 We are seeking an experienced Regulatory Affairs Specialist with over 5 years of experience in medical devices. The ideal candidate will have a strong background in registering products both within Egypt, internationally and the ability to manage regulatory processes efficiently across multiple markets. This role requires excellent knowledge of local and global regulatory requirements, along with a proactive approach to ensuring compliance and timely product approvals.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Manage and oversee regulatory submissions for medical devices in Egypt and international markets.
 </li>
 <li>
 Prepare, review and submit registration dossiers in compliance with local and global regulatory requirements.
 </li>
 <li>
 Liaise with regulatory authorities to ensure timely approvals and address any queries or deficiencies.
 </li>
 <li>
 Maintain and update product registrations, including variations, renewals and post-marketing requirements.
 </li>
 <li>
 Ensure compliance with applicable laws, guidelines and standards.
 </li>
 <li>
 Coordinate with internal departments (quality, production, marketing) to gather necessary documentation.
 </li>
 <li>
 Monitor changes in regulatory regulations and communicate impacts to the business.
 </li>
 <li>
 Support product lifecycle management and regulatory strategy planning.
 </li>
 </ul>
 
 
 
 
 
 Qualifications &amp; Requirements:
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy, Medicine, or a related field.
 </li>
 <li>
 Minimum of 5 years of experience in Regulatory Affairs within the medical device industry.
 </li>
 <li>
 Proven experience in registering products in Egypt and other international markets.
 </li>
 <li>
 Strong knowledge of Egyptian Drug Authority (EDA) regulations and international regulatory frameworks.
 </li>
 <li>
 Excellent documentation and dossier preparation skills.
 </li>
 <li>
 Strong communication and organizational skills.
 </li>
 <li>
 Ability to work independently and manage multiple projects simultaneously.
 </li>
 <li>
 Willingness and ability to travel when required.
 </li>
 </ul>
 
 
 
 
 
 Preferred Skills:
 
 
 <ul>
 <li>
 Experience with
 
 medical devices, including CGM (Continuous Glucose Monitoring), is a plus
 
 .
 </li>
 <li>
 Familiarity with CTD/eCTD formats.
 </li>
 </ul>
 
 
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Regulatory Affairs Specialist

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POS Enterprise

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Regulatory Affairs Specialist