Quality Assurance Executive
2 weeks ago
1. Handling regulatory assistant tasks. 2. In charge for technical regulatory requirement for country registration matter including product (medical glove) registration, company registration, certification, external testing, product & standard compliance especially regulatory requirement of U.S Food & Drug Administration (US FDA) & Malaysia Medical Device Authority (MDA) 3. Assist marketing in response to customer requests for regulatory and product information, such as product data, written regulatory affairs statements. 4. ISO 13485 document control (eg. document changes, document records and lists). 5. Other country regulations when necessary and up to date on MDA regulation. 6. To monitor date and regulatory affairs department gnat charts. 7. Perform general filing duties and maintain organized documentation. 8. Provide administrative support including photocopy, scanning and etc. 9. Perform any other tasks and duties assigned by the superior. 10. Years of Experience - 1 year / fresh grad also welcome 11. Expected salary - RM1,700-RM 2,000
AVECENA GLOVES SDN BHD LOT 50592, SENDAYAN TECHVALLEY 1/1, BANDAR SRI SENDAYAN, 71950, SEREMBAN, NEGERI SEMBILAN.
Bachelor's or Equivalent
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