Regulatory affairs technical officer

A leading medical supplies manufacturing company based in Riyadh is seeking a Regulatory Affairs Technical Officer to support and coordinate regulatory activities and ensure compliance with SFDA, FDA, MDR, and ISO 13485 standards. The candidate will be responsible for maintaining technical documentation and engaging with both internal quality teams and external regulatory bodies.

• Provide Level 1 and Level 2 technical support related to regulatory submissions.
• Prepare and update technical documentation (e.g., Risk Management Files, Verification Reports, PMS plans) in compliance with SFDA, FDA, MDR, and ISO 13485.
• Submit regulatory files and documents to local and international authorities as required.
• Interpret and apply global regulatory frameworks to ensure full product compliance.
• Coordinate closely with the Quality Department for alignment on compliance matters.
• Draft clear and professional technical reports for both internal and external use.
• Actively support audit and inspection readiness efforts.

• Bachelor's degree in Pharmacy, Chemistry, Biomedical Engineering, or a related scientific or technical field.
• 0-1 year experience 
• Quick learner.
• The company offers comprehensive training in regulatory processes and documentation standards to ensure a successful onboarding experience.
• Strong English skills in both reading and writing are essential for reviewing regulatory requirements, preparing documentation, and communicating with global partners.
• Effective Communication
• Time Management
• Team Collaboration
• Analytical Thinking
• Regulatory Compliance (SFDA, FDA, MDR, ISO 13485)
• Technical Documentation Preparation
• Risk Management & Post-Market Surveillance
• Audit Support & Quality Coordination