Regulatory Affairs Executives

1 day ago

Kuala Lumpur, Malaysia AG Staffing Malaysia Full time

**Regulatory Affairs Executives (GDPMD/Regulatory Affairs of Medical Devices)**

This position’s primary responsibility is handling Regulatory Affairs (RA) tasks, including product registration, license management, and compliance.

This role is designed with Business Continuity Planning (BCP) in mind, ensuring that both staff members can support each other’s responsibilities when needed.

**Key Responsibilities**:
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.

**Preferences**:

- Bachelor’s degree in Life Sciences, Pharmacy, Biomedical, Business Administration, or related field.
- Ideally with at least 3 years of hands-on experience in Regulatory Affairs of medical device.
- Knowledge of ASEAN medical device regulations is an advantage.
- Strong organizational, documentation, and multitasking skills.
- High attention to detail with a strong compliance mindset.
- Good communication skills in English (written and spoken).
- Proficiency in MS Office; familiarity with regulatory or CRM systems is a plus.

**Reporting Line**:

- Reports to: Managing Director / General Manager
- Works closely with: Existing RA & Admin staff, Sales & Marketing, HQ RA teams.

**Growth Opportunities**:

- Develop expertise in ASEAN regulatory frameworks.
- Advance into a Senior RA Specialist or Regulatory Affairs Manager role.
- Gain exposure to cross-functional operations, strengthening versatility in administration and compliance.

**Job Types**: Full-time, Permanent

Pay: RM5,000.00 - RM7,500.00 per month

Work Location: In person

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