Regulatory Affairs

Abdullah Baghaffar Sons Company; Jeddah; On-site; SAR 150,000 - 200,000; Full time

Job summary

A leading healthcare company in Jeddah is seeking an experienced Regulatory Affairs Officer. The role involves managing all regulatory activities for medical devices, ensuring compliance with SFDA and relevant authorities. Ideal candidates must hold a Bachelor’s degree and have 2–4 years of relevant experience. This position offers a competitive salary, benefits, and growth opportunities within an expanding organization.

Benefits

Competitive salary and benefits package

Growth opportunities within the organization

Collaborative work environment

Qualifications

• 2–4 years of experience in Regulatory Affairs within medical devices.
• Strong knowledge of SFDA e-portal and customs clearance procedures.
• Excellent communication skills in English and Arabic.

Responsibilities

• Prepare, submit, and track MDMA applications with SFDA.
• Coordinate product registrations and renewals in compliance with regulations.
• Ensure products meet SFDA and international regulatory requirements.
• Manage importation processes and customs clearance documentation.

Skills

Regulatory knowledge

Communication skills

Organizational skills

Attention to detail

Education

Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or related field

Job description

Overview

We are seeking a detail-oriented and experienced Regulatory Affairs Officer to join our team in Jeddah. The ideal candidate will be responsible for managing all regulatory activities related to medical devices and healthcare products, ensuring full compliance with SFDA (Saudi Food & Drug Authority) and other relevant authorities.

Responsibilities

• Prepare, submit, and follow up on MDMA (Medical Device Marketing Authorization) applications with SFDA.
• Coordinate and maintain product registrations, renewals, and variations in compliance with local regulations.
• Ensure all products meet SFDA, GHTF, IMDRF and international regulatory requirements.
• Liaise with suppliers, manufacturers, and distributors to obtain and compile regulatory documentation.
• Manage the importation process, including preparation and submission of clearance documents for shipment release.
• Follow up with customs brokers, clearing agents, and SFDA inspectors to ensure timely clearance of shipments.
• Ensure correct labeling, documentation, and product classification according to SFDA guidelines.
• Monitor regulatory updates, circulars, and announcements to ensure company compliance at all times.
• Assist in audits, inspections, and internal compliance reviews.
• Maintain a regulatory database and proper filing system for all approvals, licenses, and permits.

Qualifications & Requirements

• Bachelor’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
• Proven experience (2–4 years) in Regulatory Affairs within the medical device (NEW IVDR REGULATIONS) in KSA.
• Strong knowledge of SFDA e-portal (GHAD, MDMA, SABER) and customs clearance procedures.
• Excellent communication skills in both English and Arabic.
• Strong organizational skills and attention to detail.
• Ability to work independently and handle multiple regulatory projects simultaneously.

What We Offer

• Competitive salary and benefits package.
• Opportunity to grow within a dynamic and expanding organization.
• A professional and collaborative work environment.