Regulatory Affairs Manager| Officer – Medical Devices
Job in
Riyadh, Riyadh Region, Saudi Arabia
Listed on 2025-12-02
Listing for:
RAWAJ
Full Time
position Listed on 2025-12-02
Job specializations:
-
Healthcare
Medical Device Industry, Healthcare Compliance, Medical Science Liaison
Job Description & How to Apply Below
Leverage your abilities and join a leading medical device manufacturer driving compliance and innovation across Saudi Arabia.
The Regulatory Affairs Manager ensures all medical devices comply with SFDA and international standards by managing product registrations, renewals, and documentation.
Key Accountabilities- 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.
- 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.
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