Regulatory Affairs/Quality Assurance (RA/QA)

• May 2023 - Present

• Responsible for regulatory compliance of medical device, licenses and intellectual property. Prepare documents for new submission or renewal of medical device registration application • Maintain regulatory files and records to track progress of registration applications. Provide reports on registration or other activities as required • Prepare schedule of current and planned registration activities. Organize and ensure timely renewal of product registrations and licenses • Review company’s practices in compliance to regulatory requirement • Advising on regulatory requirement, legal and scientific restraints and requirement • Maintain familiarity with current industry practices that affect regulatory affairs function • Involved in the development of product marketing concept (to approve packaging and advertising before product is being used commercially) • Review and approve technical content of promotional material as necessary. Review packaging texts to ensure in compliance with registration and legal requirements • Liaise with Production and Quality Control departments to obtain data required in support of registration applications Show less

Technical Clinical Executive

• Aug 2022 - Present

• Assist Chief Technology Officer (CTO) by performing project-related work, as needed, or requested • Provides guidance on the potential uses of healthcare technology/services and outlines the opportunities and limitations of the technology/services • Responsible for evaluation and research in the areas of healthcare equipment utilization, cost benefit analysis, and clinical efficiency and outcomes • Identify, analyze and gather healthcare technology/services requirements/information and develop technical specifications • Create project and operational support documentation, which may include business requirement documents, clinical paper, implementation plans, and reporting of results • Responsible for making timely, effective decisions in relation to assigned healthcare technology products and services tasks • Provide support to other departments with regard to the provision of technical information • Assist in internal audit process • Effectively works as part of a multidisciplinary healthcare team to identify solutions to improve efficiency and the delivery of medical technology Show less

• Mar 2021 - Aug 2022

Main Responsibilities (Administrative Duties):• Data transcription, results interfacing, and release of results (final verification of test reports) into BP Lab Information System (BP LIS), within the given turn-around-time; 24Hrs TAT• Attend to all emails and WhatsApp tracing daily, and alert the lab team about the urgency of samples• Registration and bulk registration of clinic and hospital KKM samples into the system accordingly, and ensured that the sample amount received are tallied with request forms• To answer any inquiries from doctors, to conduct investigations on customer complaints, and to conduct corrective actions and preventive actions of any non-conformance• Maintain confidentiality of patients information gained in the conduct of testing, and not disclose the results or information to unauthorized persons, without the consent of the person concernTechnical Duties:• Validate and verify all tests conducted with valid internal quality control• Validate and verify all results from machines before release results into LIS• Coordinated with the IT team on the implementation and optimization of LIS, and to provided feedback on the system interfacing, enhancement or fix issues• To assist manager in oversee the whole lab operations and to notify critical test results• Provided technical training’s on lab workflow to new staffs• Ensured a smooth running of operation and staff matters (e.g. morale, optimum work allocation, interdepartmental relationship, schedule planning, leave coverage)General Duties:• To multitask and lend a helping hand in different workstation simultaneously when sample surge or load is high, to ensure the TAT is achieved• In-charge on stock count inventory, ensured the stocks are adequately maintained, and liaised with the purchasing department for the arrival of new stock of consumables and reagents• Assisted on the documentation preparation for ISO lab audit and ensured all documentations are maintained in proper Show less

• Jun 2020 - Feb 2021

1) Conducted qualitative screening of viral nucleic acid for Novel Coronavirus 2019-nCoV of the following work:• Reviewed the sample condition upon receival, and ensured that the sample amount received are tallied with log sheets or request forms• Sorted the samples by prioritizing to its urgency, incubated the swab samples, and registered the samples into the database accordingly, before proceeding for nucleic acid extraction (RNA extraction)• Prepared RNA extraction buffers followed by sample loading into 96-well plate for RNA extraction• Prepared RT-PCR mastermix and transferred extracted RNA samples; either in 96-well plate reaction (manual run) or 384-well plate reaction (operation of automated liquid handling platform)• RT-PCR curve and CT value analysis in thermocycler by interpreting the fluorescence signals• Administration work, result interfacing, report validation and final verification, and result tracing• Verified results reported to the requestor within the given turn-around-time (within 24Hrs TAT)• Maintain a responsible approach concerning the handling and disposal of hazardous material2) Conducted DNA and RNA viral load of hepatitis virus (Hepatitis B and Hepatitis C) serum samples, and human papillomavirus cytology samples via Roche Hamilton Cobas 4800 System Show less

• Jun 2020 - Jul 2020

• Performed ELISA screening for Hepatitis B, Hepatitis C and IgG• Conducted immunology screening of blood serum samples via Abbott Alinity CI• Data entry validation

Marketing Executive

• Aug 2019 - Jan 2020

• Recruited and enrolled qualified students to the University, accelerating average monthly sales of 80% • Analyzed marketing strategies and implemented marketing directions to the team • Provided consultation and guidance on enrolment requirements and related issues • Provided information on the courses offered to prospective and existing students • Maintained consistent contact with students throughout the enrolment process • Assisted in preparation of marketing events (e.g. roadshows, interviews and career fair), budget and sales report, and administrative duties Show less

• Jun 2018 - Dec 2018

• Schottky diode fabrication• Acquisition of Current-Voltage (I-V) curve of biological samples (nucleic acids and whole-cells) in LabVIEW• Data analysis and calculation of solid-state parameters• Optimization of I-V results with biological and technical replicates of samples• Supervised undergraduates working on the research project and monitored their progress• Prepared proposal writing for grant submissions and patent filing, and monitored the project budget

• Feb 2018 - Jun 2018

• Gene expression studies of shrimps viruses in aquaculture farms• Supervised undergraduates working on the research project and monitored their progress• Prepared proposal writing for grant submissions and patent filing, and monitored the project budget• Procured laboratory equipment supplies and recorded inventory counts for audit inspections

• Jul 2017 - Jan 2018

• Isolation and species identification of toxic algae and cyanobacteria• DNA amplification of microcystin gene (toxin gene) in cyanobacteria• Gene expression studies of algae and cyanobacteria

Sales And Marketing Representative

• Jan 2013 - Aug 2013

• Generated an average weekly sales of RM3000 • Conducted training and development modules on team building • Provided marketing directions and boosted confidence to the team members • Responsible in recording inventory counts during stock arrival • Generated an average weekly sales of RM3000 • Conducted training and development modules on team building • Provided marketing directions and boosted confidence to the team members • Responsible in recording inventory counts during stock arrival