Regulatory Affairs Specialist

Almarfa Medical is a leading organization dedicated to introducing the latest innovative medical products to specialty medical centers throughout Saudi Arabia. Our efforts are powered by a highly qualified team of consultants and salespeople, operating as a full-service organization that facilitates collaboration between medical product manufacturers and hospitals across the Kingdom.

Job Purpose The Regulatory Affairs Specialist is responsible for ensuring that all medical devices marketed and distributed by Almarfa Medical comply with the regulatory requirements of the Saudi Food and Drug Authority (SFDA). The role focuses on registration, renewal, and maintenance of medical device marketing authorizations, ensuring timely approvals and full regulatory compliance throughout the product lifecycle.

Key Responsibilities

Prepare, compile, and submit medical device registration dossiers in compliance with

SFDA MDS-REQ-1

and related guidelines.

Coordinate and communicate with SFDA reviewers during submission and evaluation phases to address comments and provide clarifications.

Manage the registration and licensing of new products, facilities, and importers in the

GHAD system .

Ensure proper documentation and compliance with SFDA requirements for labeling, bundling, classification, and post‑market surveillance.

Maintain and update the Medical Device Marketing Authorization (MDMA) and ensure timely renewals before expiration.

Collaborate with manufacturers and principals to collect technical documentation, including technical files, QMS certificates, risk‑management reports, and clinical evaluations.

Review and verify compliance of I‑FUs, packaging, and labeling with local regulatory standards.

Monitor changes in SFDA regulations and communicate updates to internal teams and international partners.

Support internal audits, ISO 13485 : 2016 compliance, and quality‑management activities related to regulatory documentation.

Keep detailed records of all submissions, approvals, and correspondences with SFDA.

Qualifications and Skills

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

Minimum 2–4 years of experience in SFDA medical device registration or similar regulatory affairs role.

Strong knowledge of SFDA Medical Device Interim Regulation.

Familiarity with ISO 13485 and ISO 14971 standards.

Excellent written and verbal communication skills in English and Arabic.

Strong organizational skills and attention to detail.

Ability to manage multiple submissions and deadlines efficiently.

Preferred Attributes

Experience with cardiovascular, surgical, or oncology medical devices.

Prior work in a multinational or authorized representative company.

Proficiency in the SFDA GHAD platform and e‑services.

Please send your CV to

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