Regulatory Affairs & Administration ExecutiveID:58430

4,500 MYR ~ 6,500 MYRCheras (KL)4 days ago

Overview

  • 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 holiday

  • Job Function