Job Summary:

We are seeking a skilled and detail-oriented Regulatory Affairs Specialist to support regulatory compliance activities for medical devices in Saudi Arabia. The role involves managing SFDA regulatory submissions, maintaining product registrations, and ensuring compliance with applicable regulations throughout the product lifecycle.

Key Responsibilities:

Prepare, submit, and follow up on regulatory applications, including:

MDMA (Medical Device Marketing Authorization)

Authorized Representative (AR) registration

Importation licenses and permits

Maintain regulatory records and ensure continuous compliance with SFDA requirements

Monitor application status and coordinate with SFDA for approvals, renewals, and variations

Prepare and review technical documentation

Declarations and certificates

Support post-market regulatory activities,

Vigilance reporting (FSN/Recall)

Product updates and amendments

Coordinate with manufacturers, suppliers, and internal teams to collect required regulatory documents

Ensure compliance with applicable Saudi regulations (e.g., MDS requirements)

Maintain internal regulatory databases and tracking systems

Support internal audits and regulatory inspections

Qualifications

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

2–5 years of experience in Regulatory Affairs (medical devices preferred)

Strong knowledge of SFDA medical device regulations and submission processes

Experience with MDMA and regulatory lifecycle management

Skills & Competencies

Strong attention to detail and documentation accuracy

Excellent communication and coordination skills

Ability to manage multiple submissions and deadlines

Familiarity with regulatory systems and tracking tools

Proficiency in English (written and spoken); Arabic is a plus

Familiarity with documentation and coordination with international manufacturers is an advantage

Ability to work in a fast-paced, multicultural team environment

What We Offer

Competitive salary and benefits

Opportunity to work in a leading medical device distribution company

Professional growth in regulatory and compliance field

Please apply only if your qualifications and experience match the above requirements.

Send your CV to:

راجع بيانات البريد الالكتروني على وظفنا دوت كوم