Regulatory Affairs Executive at Malaysian Healthcare Sdn Bhd (2025-11 – Present)
- Liaised with international manufacturers to prepare, review, and submit medical device registration and renewal dossiers in compliance with the Medical Device Act 2012 (Act 737).
- Managed the company's MDA Establishment Licence, including renewals, validity monitoring, and regulatory documentation.
- Planned and coordinated GDPMD internal audits, including audit scheduling, document control, Management Review Meetings (MRM), CAPA implementation, and audit follow-up.
- Served as the Document Controller and Internal Auditor to maintain GDPMD compliance and audit readiness.
- Prepared, submitted, and monitored licence applications and renewals with CIDB, Suruhanjaya Tenaga, SEDA and SIRIM.
- Reviewed, verified and compiled, supporting documentation received from manufacturers before submitting it to the CAB for full conformity assessment of medical devices without pre-market approval from MDA-recognised reference regulatory authorities.
- Reviewed, verified and compiled, supporting documents for Product Verification applications for Class B, Class C, and Class D medical devices before submission to the Conformity Assessment Body (CAB).
- Monitored the validity of licences, certificates, and regulatory approval to ensure continuous compliance and timely renewals.
- Managed MedCAST submissions, including change notifications and regulatory updates for registered medical devices.
- Coordinated QMS documentation and audit evidence preparation for ISO 9001 surveillance and recertification audits to maintain ISO 9001 certification compliance.
- Collaborated with cross-functional teams to obtain technical and regulatory documentation for product registrations, licence renewals, regulatory submissions, and audits.
- Developed and implemented internal regulatory procedures to strengthen compliance with GDPMD requirements and the Medical Device Act 2012 (Act 737).
- Provided regulatory guidance to management on compliance requirements, regulatory matters, and special projects.
- Reviewed regulatory updates and implemented procedural improvements to ensure continued compliance with current MDA requirements.
Service Coordinator at LAC Medical Supplies Sdn Bhd (2025-08 – 2025-10)
- Coordinated preventive maintenance (PPM), installations, and breakdown services with technical teams and customers; developed engineer schedules and ensured availability of EST tools.
- Managed service tracking in the Caction system by assigning jobs, enabling engineers to check in, upload documents, and close tasks efficiently.
- Collected and organized service reports, PPM checklists, and TNC certificates; updated job statuses in the master list for compliance.
- Maintained filing systems by archiving digital and hard copies of signed reports and certificates, ensuring audit readiness.
- Prepared installation documentation, including user manuals, service manuals, training certificates, MDA certificates, letters of authorization, calibration records, and serial number attachments.
- Prepared quotations and order confirmations for ad-hoc maintenance, breakdowns, and spare parts after verifying pricing with the Head of Department.
- Drafted and processed service contract proposals; coordinated LHDN stamping and distributed finalized copies to clients.
- Verified and approved engineer claims in CRM by cross-checking receipts and bills for accurate reimbursement.
- Arranged flight and hotel bookings for engineers, aligning travel logistics with service schedules.
- Handled customer enquiries via phone, providing professional explanations and timely solutions.
- Supported departmental operations by performing additional tasks assigned by superiors, demonstrating flexibility and teamwork.
Executive Planner/Engineer Production at Top Glove F18 (2024-10 – 2025-08)
- Managed production planning and packing operations to ensure smooth workflow and timely output.
- Evaluated Weekly Sales Reviews (WSR), analysed data, and generated forecasts to support planning.
- Coordinated with Marketing, Shipping, and purchasing departments to streamline sales order processing.
- Liaised with Production, QA, and Shipping teams to ensure timely container deliveries.
- Monitored production and packing outputs, consistently meeting daily targets and quality standards.
- Collaborated with Shipping and other factories to coordinate combined shipment orders.
- Followed up with Purchasing to ensure timely procurement of packing materials.
- Partnered with QA to resolve product quality issues and maintain customer satisfaction.
- Issued work orders and arranged daily packing activities in line with schedules.
- Maintained accurate planning transactions and inventory updates using SAP.
- Oversaw glove quality control, ensuring targets were achieved without compromising standards.
- Provided technical support and engineering expertise to production workers.
- Assisted workers in data analysis and troubleshooting of production issues.
- Improved process consistency by applying engineering best practices.
- Prepared purchase requisitions and recorded goods receipts in SAP to maintain inventory accuracy.
- Optimized the tumbling process to achieve 100% separation of sticky gloves, enabling rework and resale of previously unsellable stock, resulting in additional profit for the company.
Electronic Engineer at Medical Device Authority (2023-07 – 2023-10)
POST MARKET SURVEILLANCE AND VIGILANCE DEPARTMENT
- Investigated complaints through Mandatory Problem Reporting (MPR), including patient burn incidents with the FORCE FX Electrosurgical Generator; compiled device specifications, registration status, and incident background, and presented findings to enforcement officers.
- Conducted post-market enforcement investigations, such as the BIOAQUACELL Eye Drops case; confirmed prohibited ingredients via laboratory testing, joined on-site inspections, and observed enforcement actions against non-compliant manufacturers.
- Reviewed and analysed user complaints for devices like the TERA-P90 PEMF therapy device; assessed manuals and usage instructions, identified probable user error, and presented findings to MDA staff.
- Performed market surveillance of medical devices sold on Shopee and Lazada; verified registration using the MDA Public Search system and compiled Excel reports categorizing registered and unregistered devices.
- Gained practical exposure to MEDCAST, MDA's centralized platform for MPR, including complaint submission, tracking, and regulatory documentation.
- Participated in Conformity Assessment Body Training covering Medical Device Regulations (2012, 2019), CAB registration requirements, device classification, Good Distribution Practice for Medical Devices, and Clinical Evaluation (CSDT and EPSP).
Electronic Engineer at Radicare (M) Sdn Bhd (2019-12 – 2020-03)
- Conducted performance testing on Philips Efficia DFM100 Defibrillator using analyser and ECG simulator; verified energy delivery, charging time, waveform display, synchronized cardioversion, alarm conditions, and display clarity.
- Performed electrical safety testing on Philips Efficia DFM100 Defibrillator in accordance with IEC 60601-1 standards using Fluke Impulse 7000DP; verified earth continuity, insulation resistance, leakage currents, and safe operation.
- Executed extended self-test on GE Carespace R860 Ventilator following manufacturer protocols; connected test lung and patient circuit, evaluated valve operation and alarms, monitored calibration accuracy, corrected expiratory valve errors, and confirmed clinical readiness.
- Carried out planned preventive maintenance on neonatal incubators; inspected heater and fan operation, verified sensor calibration, tested alarm responses, checked display clarity, cleaned filters and compartments, and ensured safe clinical use.
- Prepared and managed documentation for breakdown work orders, preventive maintenance, and electrical safety testing; completed schedules with asset details, uploaded records into ASIS Hospital Management System, and maintained organized files for compliance.
