Job Opportunities in Malaysia

Key Job Responsibilities:

• Ensure that the company’s products comply with country regulations.
• Be responsible for sending gloves for testing and following up, including filling out the necessary documents and coordinating the testing of products with external labs.
• Assist the superior in preparing Purchase Requisitions (PR) for glove testing and ensure that payments are made accordingly.
• Provide feedback to Sales & Marketing and Customer Care personnel regarding information pertaining to testing.
• Update external documents on new revisions such as standards, regulations, and guidance.
• Update training materials and procedures according to updated standards and regulations for relevant countries.
• Update the company's website with the latest standards and regulations.
• Update the product portfolio every six months.
• Ensure that quality standards are met, and submissions meet strict deadlines.
• Update and maintain FMEA, Risk Management Files, Post Market Surveillance, and Clinical Evaluation.
• Be subject to transfer to other departments at the discretion of the company.
• Ensure that RA areas and storage areas are in audit-ready status at all times and that GDP and c GMP are followed.
• Ensure that all activities related to work do not impact the environment and comply with Good Environmental Practices (GEP).
• Ensure compliance with all relevant legislation, such as OSHA, FMA, EQA, etc.
• Perform any other assignments as assigned from time to time.

Requirements:

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Regulatory Affairs) is preferred.
• Preferably 2-5 years of experience in Regulatory Affairs, Quality Assurance, or a Testing Laboratory environment.
• Familiarity with regulatory standards and requirements applicable to medical devices or consumer products.
• Strong organizational skills and attention to detail.
• Excellent communication and interpersonal skills to collaborate effectively with cross-functional teams.

Job Type: Permanent
Pay: RM3,500.00 - RM5,000.00 per month
Schedule:

• Monday to Friday

Ability to commute/relocate:

• Sitiawan: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

• Notice Period

Experience:

• Regulatory Affairs: 3 years (Required)
• Laboratory Testing: 2 years (Preferred)
• Manufacturing Industry: 2 years (Preferred)