Regulatory Affairs & Administration ExecutiveID:58430
4,500 MYR ~ 6,500 MYRCheras (KL)4 days agoOverview
Salary
4,500 MYR ~ 6,500 MYR
Industry
-
Job Description
<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.
Qualifications
Requirement
- 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.English Level
-
Other Language
English
Additional Information
Benefit
<Benefits>
- Meal allowance: RM 100 / month,
- Transportation allowance: RM 200 / month
- Once a year bonus. (Based on company performance)
- Outpatient medical expenses: up to RM 2,000 per year.Working Hour
0900 ~ 1800
Holiday
<Holidays>
- AL 14 days +1 per year
- ML - 14 days (<2 years), 16 days (>2 to 4 years), 18 days (> 4 years)
- Based on Malaysia KL holidayJob Function
Please sign in.