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Regulatory Affairs Manager| Officer – Medical Devices | Saudi Arabia
وصف الوظيفة
The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.
المسؤوليات
- Prepare, review, and submit regulatory files, technical documentation, and ESTD to SFDA
- Manage communication with SFDA authorities for product approvals and renewals
- Track and interpret new regulations impacting medical device compliance
- Maintain product registration database and ensure documentation accuracy
- Collaborate with QA, R&D, and Production to ensure regulatory alignment
المؤهلات
- Bachelor’s degree in Pharmacy, Biomedical Engineering, or Science
- 8+ years of experience in Regulatory Affairs for medical devices
- Solid knowledge of SFDA requirements, ISO 13485, and MDSAP
- Strong documentation and submission management skills
- Excellent English communication