Experienced Regulatory and Quality Manager with a 12-year tenure in a Medical Devices company, adept at ensuring compliance with SFDA regulations. Skilled in formulating and enforcing compliance policies compliant with current legislation, and steadfast in upholding the highest ethical and regulatory standards.
SFDA Regulatory Compliance: Deep expertise in SFDA regulations for medical devices.
Product Registration: Proficient in SFDA product registration, ensuring accuracy and timeliness.
Compliance Management: Vigilant in overseeing product and practice compliance with local standards.
SFDA Liaison: Effective communicator with SFDA, managing regulatory interactions.
Documentation Management: Oversaw accurate and compliant regulatory documentation.
Market Surveillance: Stayed current with changes in regulatory legislation.
QMS Maintenance and Internal Audits: Maintained the company's QMS, ensuring continuous compliance and efficiency. Conducted thorough internal audits, identifying areas for improvement.
Management Representative: Served as the primary management representative in quality matters, liaising between management and regulatory bodies.
SFDA Compliance Assurance: Diligently ensured adherence to all SFDA regulatory standards and guidelines.
Recall Management
Certified Internal Auditor for Quality Management System (ISO 9001:2015) - TÜV Middle East, Riyadh, Saudi Arabia, January 2024 (Certificate No. QMS/01/2024/1510)