Regulatory Affairs Manager Officer - Medical Devices Saudi Arabia

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.

Knowledge, Skills, and Experience

• 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.