Ensure all imported medical devices and biotech products comply with Egyptian regulatory requirements. Manage product registrations and licensing processes.
Key Responsibilities
Manage medical device registration with EDA
Prepare and submit regulatory documentation
Ensure compliance with ISO 13485 and other quality standards
Liaise with regulatory authorities in Egypt
Stay updated on regulatory changes and advise management
Requirements
3+ years of regulatory affairs experience in medical devices
Knowledge of EDA registration processes
Understanding of ISO 13485, CE marking, and FDA requirements
Strong attention to detail and documentation skills
Bachelor’s degree in Pharmacy, Science, or Engineering
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