Profile of NUR AMELA JAAFAR
NUR AMELA JAAFAR Regulatory Affairs Specialist I Compliance and Documentation I Admin Support I Post Market Quality Specialist Regulatory and Quality professional with over 15 years of experience across medical devices, cosmetics, healthcare, FMCG, agrochemical, and manufacturing industries. Highly skilled in product registration, regulatory compliance, post-market surveillance, audits, CAPA management, and customer complaint handling.
Experienced in preparing and submitting regulatory dossiers to Malaysian and international authorities including MDA, NPRA, Pesticide Board, SIRIM, Suruhanjaya Tenaga, and ACRi Taiwan, ensuring timely approvals and full regulatory compliance.
Strong track record in working with cross-functional, regional, and global teams to drive regulatory and quality initiatives from product development through to market launch. Adept in implementing ISO 13485, ISO 9001, ISO/TS 16949, and GDPMD standards, as well as managing quality systems, audits, and supplier quality performance.
Also experienced in laboratory testing, material analysis, process control, and continuous improvement initiatives, with a strong commitment to operational excellence and compliance.
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