Regulatory Affairs Manager| Officer – Medical Devices | Saudi Arabia

RAWAJ; Riyadh; On-site; SAR 150,000 - 200,000; Full time

Job summary

A leading medical device manufacturer is seeking a Regulatory Affairs Manager to oversee compliance with SFDA and international standards. The ideal candidate will have over 8 years of experience in regulatory affairs for medical devices, strong knowledge of SFDA requirements, and excellent documentation management skills. This role ensures that all medical devices are properly registered and maintained with the necessary authorities.

Qualifications

• 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.

Responsibilities

• Prepare, review, and submit regulatory files to SFDA.
• Manage communication with SFDA authorities for approvals and renewals.
• Track and interpret new regulations impacting compliance.

Skills

Regulatory compliance knowledge

Documentation management

Communication skills

Education

Bachelor’s degree in Pharmacy, Biomedical Engineering, or Science

Job description

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.