Job Description

 Regulatory Affairs (Primary Role)
- Maintain GDPMD certification, Establishment License, and related QMS systems in compliance with Malaysian regulations.
- Support internal and external audits, ensuring documentation and processes remain inspection ready.
- Maintain product licenses within the MMM territory, in cooperation with HQ in Japan and local distributors in ASEAN countries.
- Track license renewal timelines and ensure timely submissions.
- Liaise with local distributors, regulatory authorities, and HQ to resolve compliance matters.
- Prepare, submit, and manage product registration dossiers with local authorities.
- Monitor regulatory changes and update internal processes accordingly.

Administration & Operational Support (Secondary Role)
- Assist in documentation and record management (meeting minutes, filing, contracts).
- Support data entry and reporting (sales/customer lists, CRM/ERP in future).
- Help manage samples, consumables, and office equipment.
- Support business travel arrangements, event scheduling, and expense settlements.
- Assist in HR/Finance tasks such as attendance tracking, expense verification, insurance administration, and vendor payments. 

Benefits:

 -AL
-ML
-Meal allowance
-Transportation allowance
- Once a year (September) Amount subject to company performance
-Outpatient medical expenses

-Life and disability insurance coverage, Hospitalization insurance coverage 

Job Requirements

- Education Background : Bachelor’s degree in Life Sciences, Pharmacy, Biomedical, Business Administration, or related
field.
- Experience : Minimum 3 year of hands-on experience in Regulatory Affairs of medical device.
- Require Skill : Knowledge of ASEAN medical device regulations is an advantage. 

Skills