Regulatory Affair Executive

Job Title: Regulatory Affairs Executive

Company: Lienteh Technology Sdn. Bhd.

About Us:

Lienteh Technology Sdn. Bhd. is a rapidly growing company specializing in the manufacturing and distribution of medical-grade gloves. Our mission is to replicate the contributions of Wu Lien Teh, a pioneer in disease control, in a time of unprecedented disease outbreak.

Key Responsibilities:

1. Ensure the ISO 13485 quality management system/regulatory compliance system is established, implemented, and maintained, including the renewal of establishment licenses and product registration licenses with the Medical Device Authority (MDA).
2. Write, obtain approval, implement, and train organizational personnel on the organization's Document Control for the Quality System.
3. Perform internal audits and address non-conformities from previous internal and external audits.
4. Conduct a Management Review of the Quality System and follow up on the closure of the findings.
5. Search, analyze, review, and summarize the latest standard and regulation requirements for the glove segment.
6. Liaise with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow up of submissions under review for establishment and product registration, especially for the glove segment.
7. Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
8. Assist in external registration/licensing requirements. Manage and control all aspects of the Company's Quality Program, including receiving, in-process, and final inspection to ensure that products consistently meet specific and implied quality and performance standards.

Requirements:

1. Minimum Degree Holder or equivalent of education level.
2. At least 2 years working experience.
3. Experience with ISO 13485 or ISO related company.
4. Proficient in Microsoft Office.
5. Experience in Manufacturing preferred.
6. Knowledge in AQL Sampling method.
7. Knowledge in ASTM and EN standard requirements for examination gloves.

Summary of Role Requirements:

• Looking for candidates available to work:
  • Monday: Morning, Afternoon, Evening
  • Tuesday: Morning, Afternoon, Evening
  • Wednesday: Morning, Afternoon, Evening
  • Thursday: Morning, Afternoon, Evening
  • Friday: Morning, Afternoon, Evening
  • Saturday: Morning
• 1 year of relevant work experience required for this role.
• Working rights required for this role.
• Expected start date for role: 02 February 2025.
• Expected salary: $3,500 - $4,500 per month.

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