Regulatory Affair Supervisor

**JOB DESCRIPTION**
- Maintain comprehensive knowledge of the company’s product documentation.
- Keeping up to date with changes in regulatory legislation and guidelines.
- Report instances of non-compliance with customer and regulatory requirements to superiors.
- Prepare and maintain ISO documentation related to regulatory affairs.
- Prepare summary reports for post-market surveillance activities, including Adverse Event Reporting.
- Promote awareness of regulatory requirements and regulations established by country regulatory bodies.
- Implement and maintain quality systems in accordance with ISO, MDSAP, and GDPMD standards.
- Assist in all administrative tasks related to Regulatory and Quality Assurance matters.
- Assist in 2nd and 3rd party audits as required.
- Ensuring all documentation is updated and available prior in used.
- Review soft copy and hard copy of document to ensure the revision of the document.

**REQUIREMENT**:

- Preferable familiar with ISO 13845, MDSAP, BRC, International Medical Glove Standard.
- At least Diploma holder.
- Good interpersonal skill, able to read and write in English and Bahasa Malaysia.
- Strong analytical and problem-solving skills.
- Ability to adapt to evolving regulatory environments and industry standards.

Pay: RM2,000.00 - RM2,600.00 per month

Schedule:

- Monday to Friday

Work Location: In person