HomeR&D / ScienceRegulatory Affairs Officer
Regulatory Affairs Officer
Target For Medical Equipment
New Cairo, Cairo, Egypt
R&D / Science Confidential 2 months ago
Experience الخبرة
3 To 4 Years
Career Level المستوى
Experienced (Non-Manager)
Education التعليم
Bachelor's Degree
Salary الراتب
Confidential
Skills Required المهارات المطلوبة
Medical/Healthcare Quality Pharmaceutical Administration Regulatory Affairs EDA Medical Pharmacy Registration
Job Description الوصف الوظيفي
Regulatory Compliance & Strategy Ensure full compliance with EDA regulations governing medical device registration, listing, importation, and post-market activities. Interpret and apply national regulatory requirements, including guidelines and circulars issued by the EDA. Develop regulatory strategies tailored to Egyptian market timelines and requirements. Support internal teams by providing clear regulatory guidance for product development, labeling, and market introduction. Regulatory Submissions (Egypt) Prepare and submit dossiers for medical device registration to the Egyptian Drug Authority, including required administrative, technical, and quality documentation. Manage the device classification process based on EDA rules. Coordinate with EDA officials regarding inquiries, follow-up requests, inspections, or clarifications. Maintain valid registrations and ensure timely renewals, updates, and import license approvals. Documentation & Quality Compliance Support auditing processes and regulatory inspections.
Select a Category · اختر تصنيف
Login
Sign Up
Welcome back
Sign in to your Tawtheef account
Forgot password?
or continue with
Create account
Join thousands of job seekers in Egypt
or continue with