Nur Athirah Hashim

Science Officer at Medical Device Authority
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Contact Information
Location
Cyberjaya, Selangor, Malaysia, MY
Languages
  • English -
  • Malay -

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Credentials

  • Certificate of Conformity Assessment Procedures by Way of Verification
    Medical Device Authority

Experience

    • Malaysia
    • Professional Services
    • 1 - 100 Employee
    • Science Officer
      • Sep 2021 - Present
    • Assistant Director (Biomedical)
      • Jul 2016 - Present

      Medical device registration - Evaluate application for medical device registration with required approved documentation. - Evaluate either the device is consider as medical device or drugs or medical device combination. - Evaluate the medical device safety, risk classification of the medical device according to the Medical Device Regulations. - Reference for medical device registration according to the GHTF countries. - Process for medical device registration depends on each risk classification of the device itself. - Medical device-drug combination, RPE and PPE status. - Manufacturer site visit for medical device process work-flow. - Conformity Assessment Body relation for the medical device product verification. Show less

    • Sales Executive
      • May 2016 - Jul 2016

      1. OEM Health Product • Guidance provided for clients in the making of OEM products for their own brand. • Assist clients with ingredients and materials needed which correlate with health benefits. • Advice clients on the design, product packaging, price market. • Guidance with clients on registered and halal ingredients for halal certificate logo and KKM registration. 2. OEM Cosmetic Product • Guidance provided for clients in the making of OEM products for their own brand. • Assist clients with ingredients and materials needed which correlate with cosmetic benefits. • Advice clients on the design, product packaging, price market. • Guidance with clients on registered and halal ingredients and approval of NPRA for cosmetic products. Show less

    • Administrative Assistant
      • Jun 2015 - Nov 2015

      1. Vendors • Dealing with vendors’ requirement regarding their products. • Assist the sales report by the end of each month for vendors’ sales. • Keep on the update with the vendors on each product. • Stocktake update by making sure the stocktake is tally with the report. 2. Office work • Filling work for each vendors of delivery order, return order, refund, sales report. • Finance filling, close cash filling. • Microsoft office (Microsoft words, excel, powerpoint) 3. Fashion & design • Color differentiation according to the pallet. • Style and tailoring alteration. Show less

    • India
    • Hospitals and Health Care
    • 300 - 400 Employee
    • Lab Technology
      • Jan 2015 - Apr 2015

      1. Blood Bank • Perform blood collection (phlebotomy) and processing, including selecting donors, collecting blood and blood typing • Testing for blood group antigens, compatibility and antibody identification. (Coombs test, forward/reserve grouping) • Carry out blood separation procedure. 2. Clinical Pathology/Haematology • Performed automated haematology analyser with provides information on the quantity and quality of red blood cells, white and platelets. This information aids in the diagnosis of conditions such as anaemia, leukaemia, infection (dengue & malaria), snake poison. • Carry out blood smears and bone marrow slides so as to check and analyse the findings by microscope observation. • Performed urine and fecal strips test with provided information. 3. Clinical Biochemistry • Performing validation, checking abnormal results identified by automated analysers/equipment directly interfaced with LIS (Laboratory Information System) such as PT, PTT, LFT, lipid profile & drug level monitoring. • Carrying out complex biochemical analyses on body fluids using spectrophotometer and electrophoresis. Example: Detection of Sickle cell anaemia. 4. Molecular Biology • Implement DNA and RNA extraction. *QIACUBE for HBV, HCV and HSV. • Observing Polymerase Chain Reaction (PCR) *QIAGEN, only performed during selective days. 5. Microbiology (Bacteriology/Mycology/Serology) • Monitoring and identifying microorganisms’ colonies on blood agar, chocolate agar and nutrient agar. • Performed cell culture of microorganisms in isolating to standard inhibition • Performed automated antimicrobial susceptibility testing system based on strain of microbe, antibiotic resistance and potential toxicity of antimicrobial drugs 6. Histopathology • Performing grossing of routine surgical biopsies/tissue section and tissue processing • Carry out H&E stain and special stain • Operate automated equipment to dehydrate and decalcify of tissue section • Perform immunohistochemistry Show less

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