Nur Hayati Email and Phone Number

1. Regulatory submissions to the Medical Device Authority (MDA) - New registration, Re-registration, Change Notification, Demonstration for Marketing, Change of Ownership (COO), Product Classification2. Dossier reviews and submissions for Product Verification with the Conformity Assessment Body (CAB)3. Liaison and communicates with the Principal and Manufacturer for anything related to RA 4. Dossier review for regulatory submissions - Class A, B and C medical devices5. Handles post-market surveillance and vigilance notification - Field Safety Notice, Recall, Mandatory Problems Reporting6. Renewal of licenses with authorities, ministries, or statutory bodies - MDA, CIDB, and MOF7. Notification and feedback to the Atomic Energy Department for PPM - Imaging devices8. Participation in internal and external audits for GDPMD and ISO 9001:2015 - certified internal auditor for GDPMD9. Addressing and resolving non-conformities (NC) arisen from the audits accordingly10. Maintenance and control of records for GDPMD and ISO 9001:201511. Analysis of Quality Objective Achievement, Customer Satisfaction and Response Time12. Compiling and summarizing the risk registry for the Group's Enterprise Risk Management13. Updating the product registry record every three months 14. Staying up to date with new regulations and announcements from authorities, especially the MDA15. Prepares the monthly updates for RA department for the HOD meetings16. Attends virtual meetings with the Principals and Manufacturers when required17. Ad hoc tasks as required - Resolving issues with the Royal Malaysian Customs for imported goods - Assisting other departments to resolve any arising issues related to RA/QA - Add category and update information for company's MOF account

A three-months Biomedical Practicum Training with the Pathology Department of HTJS. Assigned to all six units of the department - Microbiology, Blood Bank, Hematology, Cytology, Histology and Chemical Pathology. Joined the mobile blood donation event at Gateway@KLIA2.

A three-months research internship at INHART, IIUM Gombak. Assigned to handle a project in optimizing the CG-MS by using the plant extracts. Assisted a fellow postgraduate student to conduct her studies related to microbiological activities.