Azmina Yahya

Results-driven Biomedical Science graduate with almost 7 years of experience in medical device registration/combination product registration/GDPMD compliance in Malaysia and Singapore. Expertise in pre-market applications, dossier preparation, license renewals, special access applications, change notifications, advertisement applications, and demonstration applications. Proven ability to manage product registration, regulatory compliance, and quality assurance.

Strong leadership skills in supervising projects, training staff, and handling technical inquiries. Highly meticulous, adaptable, and committed to process improvement and operational efficiency.

• Assist clients in product registration for medical devices and combination products (MD-Drug) in Malaysia (MDA & NPRA) & Singapore (HSA) through MeDC@St & Medics/SHARE portals respectively.
• Prepare dossiers for new registration, re-registration/renewal, assist in change notifications, change of ownership/license transfer, demonstration application, custom-made application, advertisement applications and special access applications.
• Work closely with MDA & HSA for any input request/additional documents required for approval.
• Work closely with Conformity Assessment Bodies (CAB) for product verification and full assessment.
• Maintain GDPMD compliance, including distribution records, complaints, and Mandatory Problem Reporting (MPR) through MeDCReSt).
• Oversee surveillance and recertification audits.
• Manage over 100+ projects, training and guiding project leads (PICs).
• Handle technical inquiries from clients and internal teams.
• Involved in recruitment and training of new staff to strengthen the regulatory and quality teams.

Master of Health Science (Biomedical Science) at Universiti Kebangsaan Malaysia (UKM) | 2016 – 2018