Education
- Bachelor of Science in Biochemistry, UTAR Malaysia
- Master of Ecotoxicology, RPTU Kaiserslautern-Landau
Experience
- 9 years in regulatory affairs medical device
- 6 years in quality management system
- 2 years in ISO 45001 and ISO 14001
Field of Expertise
- Medical devices (IVD and GMD)
- ISO Quality Management System documentation and audit
- Medical device product regulatory dossier drafting