Regulatory & Administrative Executive

Auricle Asia; Selangor; On-site; MYR 100,000 - 150,000; Full time

Job summary

An established industry player is seeking a detail-oriented Administration Executive to oversee Good Distribution Practice compliance for medical devices. In this role, you will coordinate audits, manage product registrations, and ensure timely renewals of licenses. Join a supportive team dedicated to the ethical distribution of quality products in the medical aesthetic field. If you thrive in a dynamic environment and have a passion for regulatory affairs, this opportunity is perfect for you.

Benefits

Yearly bonus with KPI

Performance incentives

Yearly company trip

Health & PA Insurance

Monthly company events

EPF, SOCSO & EIS contributions

Supportive management

Qualifications

• Degree or Diploma in Science, Pharmaceutical, or related fields required.
• Prior experience in Regulatory Affairs (GDPMD/NPRA/ISO) preferred.

Responsibilities

• Oversee GDPMD compliance, including documentation and audits.
• Coordinate product registration with authorities like MDA and NPRA.
• Act as the main contact for regulatory matters with manufacturers.

Skills

Regulatory Affairs

Attention to Detail

Time Management

Communication Skills

Education

Degree in Science

Diploma in Pharmaceutical

Job description

Job Responsibilities

1. Oversee and coordinate the company’s Good Distribution Practice for Medical Devices (GDPMD) compliance, including documentation, record-keeping, and continuous implementation.
2. Manage internal and external audits, liaising with Conformity Assessment Bodies (CABs) and operations teams to ensure GDPMD standards are maintained.
3. Coordinate product/medical device registration with relevant authorities such as the Medical Device Authority (MDA) and the National Pharmaceutical Regulatory Agency (NPRA), including dossier preparation and supporting consultants.
4. Act as the main point of contact for regulatory matters with manufacturers, MDA, NPRA, and other government agencies.
5. Ensure timely renewal of establishment & corporate licenses and monitor all company regulatory licenses and certificates.
6. Assist in reviewing regulatory documents and related agreements.
7. Responsible for executing ad-hoc administrative tasks including license renewal, letter preparation, recruitment support, etc.

Benefits

• Yearly bonus with KPI
• Performance incentives
• Yearly company trip
• Health & PA Insurance
• Monthly company events
• EPF, SOCSO & EIS contributions
• Supportive management

Requirements

• Degree or Diploma in Science, Pharmaceutical, or related fields.
• Prior experience in Regulatory Affairs (GDPMD/NPRA/ISO) is preferred.
• Attention to detail and ability to meet deadlines.
• Proficient in spoken and written English and Bahasa Malaysia.

Additional Information

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Application questions include:

• Right to work in Malaysia?
• Expected monthly salary?
• Qualifications?
• Years of experience as an Administration Executive?
• Notice period with current employer?

About the Company

Established in 2018, Auricle Laboratory is an SME specializing in the distribution of aesthetic and wellness products to medical aesthetic clinics across Malaysia. We are committed to distributing genuine, quality-proven products responsibly, ethically, and affordably.

Additional Notes

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