Regulatory Affairs Manager| Officer – Medical Devices | Saudi Arabia

Rawaj HCM Jobs; Riyadh; On-site; SAR 150,000 - 200,000; Full time

Job summary

A leading medical device manufacturer in Saudi Arabia is looking for a Regulatory Affairs Manager to ensure compliance with SFDA and international standards. Responsibilities include preparing and submitting regulatory files, managing communication with authorities, and maintaining documentation accuracy. Ideal candidates should have a Bachelor's degree in Pharmacy or Biomedical Engineering and at least 8 years of experience in Regulatory Affairs. This role offers an opportunity to drive innovation and compliance in a dynamic environment.

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.
• Track and interpret new regulations impacting compliance.
• Maintain product registration database and documentation accuracy.
• Collaborate with QA, R&D, and Production for regulatory alignment.

Skills

Regulatory Affairs

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.