合同工 Senior Regulatory Affairs Specialist 工作, 薪水 up to MYR 10,000, Manpower Staffing Services (Malaysia) Sdn. Bhd. WP Kuala Lumpur 公司招聘中 - Ricebowl

Qualification

• Strong command of English and Bahasa Malaysia (verbal and written)

• Strong understanding of Malaysia and Indonesia regulations.

• Ability to ensure accuracy in documentation, packaging, and product compliance.

• Ability to manage multiple tasks, prioritize tasks effectively, and meet deadlines.

Main responsibilities:

• Prepare, compile, submit and maintain product registrations related to registration, renewal, and license amendments of medical devices, till approval process with the Malaysian Medical Device Authority (MDA) & Ministry of Health (Kemenkes).

• Monitor submission status and support timely responses to deficiency letters and regulatory authority requests, ensuring accurate documentation of all interactions.

• Liaise with regulatory authorities, conformity assessment bodies (CAB), and other relevant authorities.

• To keep abreast of local regulatory updates, guidelines and new regulations, and its implementation.

• Ensure that the product, packaging, and labeling of the current and new products comply with the regulatory requirements.

• Perform change impact assessment for Malaysia and Indonesia.

• Perform advertisement and promotional material review in accordance with local regulations.Other tasks as assigned.

• Annual Leave
• Medical and Hospitalisation Leave
• Training Provided
• Allowance Provided
• EPF
• SOCSO
• Medical Insurance
• 5 Working Days