Kerja Kontrak Regulatory Affairs Executive, Gaji tinggi MYR 10,000 di Manpower Staffing Services (Malaysia) Sdn. Bhd. WP Kuala Lumpur - Maukerja

Qualification

• Degree in Life Science or related field.

• At least 1-2 years’ experience in Medical Device Industry.

• Experience working in a multinational environment will be advantageous.

• Proficiency in Microsoft Office Applications especially MS Word, Excel, PowerPoint and Outlook.

• Strong analytical skills and attention to detail.

• Good interpersonal and communication skills.

• Self-motivated and ability to work independently.

• Ability to multi-task effectively.

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).

• Coordinate regulatory activities related to transition

• Assess regulatory impact and requirements associated with transition projects

• Manage registration updates required for transition

• Support regulatory submissions and approvals related to product transition

• Ensure regulatory compliance during product and license transition activities

• Assist on timely submissions of new registrations and license renewals when necessary.

• Follow up on status of licenses and take necessary actions when required.

• Keep abreast of changes in regulations and ensure compliance within the organization.

• Coordinate with marketing teams to obtain relevant information and documentation for submission purposes.

• Support regulatory activities by other departments within the organization including Quality, Manufacturing, Marketing and Sales.

• Undertake additional projects and tasks as assigned by the supervising manager

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