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: candidateregulatorysfda@gma ...