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Job Description
- Develop and implement regulatory strategies for product development, approval, and lifecycle management.
- Provide regulatory guidance throughout the product lifecycle, from concept through to commercialization and post-market surveillance.
- Analyze regulations and provide guidance on regulatory requirements.
- Lead the preparation and submission of regulatory documents to relevant regulatory bodies.
- Ensure timely submission of regulatory filings, ensuring all documentation is complete and accurate.
- Monitor and ensure compliance with national and international regulations throughout the product lifecycle.
- Stay updated on changing regulations and communicate relevant updates to cross-functional teams.
- Serve as the primary point of contact for regulatory agencies and handle communication regarding product approvals, inspections, or audits.
- Respond to regulatory inquiries and provide additional information as required.
- Lead post-market surveillance activities, including monitoring and managing product complaints, adverse events, and recalls.
- Conduct regulatory assessments of product changes and ensure continued compliance.
- Educate and train internal teams on regulatory requirements and industry best practices.
- Provide regulatory support during product development, labeling, and marketing activities.
- Renewal the contracts with the foreign companies and adding and issuing the S14 from GOEIC authority and adding it on the import license for the company
- Work closely with the legal and finance teams to evaluate vendor performance data and renew contracts based on performance metrics.
- Incorporate clauses related to new regulatory requirements, product recalls, or post-market surveillance where necessary.
- Understand and manage any regional regulatory changes that may affect foreign contracts, including customs regulations, import/export requirements, or international regulatory guidelines.
- Coordinate with international teams to align contract renewals with any updates to market entry strategies, product approvals, or distribution needs.
- Work closely with the sales team to obtain the requirements for the registrations for the new products according to the market needs.
- Manage the process of applying for and renewing the warehouse license with the Ministry of Health (MOH), ensuring full compliance with all legal and regulatory requirements.
- Coordinate with relevant authorities and departments to ensure that all necessary documentation and procedures are followed in the application process.
- Ensure that the warehouse meets all the MOH's standards, including facility inspections, safety protocols, storage conditions, and regulatory requirements related to medical devices.
- Compile and maintain all necessary documentation for the warehouse license, including facility layout, storage conditions, and procedures for handling and distributing medical devices.
- Prepare for MOH inspections by ensuring the warehouse is compliant with Good Distribution Practices (GDP) and other relevant regulations.
- Address any gaps or issues raised by MOH during inspections or audits, and ensure prompt resolution to maintain licensing status.
- Serve as the primary point of contact for communications between the company and the Ministry of Health regarding warehouse licensing.
- Work closely with internal teams, such as quality assurance, regulatory affairs, and facilities management, to ensure the warehouse meets all health and safety standards.
- Dealing with the atomic authority in the radioactive products.
Job Requirements
- Medical Background (Bachelor degree in Medicine, Pharmacy , Dentistry , or science)
- 9 years + experience.
- proven experience in a medical device (sterile, non-sterile).
- solid awareness of registration procedures, variation, and other regulatory processes.
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