全职 Admin assistant 工作, 薪水 up to MYR 2,300, Perniagaan Bekalan Abadi Selangor 公司招聘中 - Ricebowl

Job Description:
We are looking for a responsible, organised and detail-oriented Regulatory Affairs Assistant to support the Regulatory Affairs team in managing regulatory documentation and ensuring compliance with applicable medical device requirements.

Key Responsibilities:

Assist in preparing, compiling and maintaining Regulatory Affairs (RA) documents and records.

Assist with MDA registration, renewal and regulatory submissions for medical devices.

Ensure all regulatory documents, certificates, licences and approvals are properly filed, updated and valid.

Monitor the expiry dates of MDA registration, licences, certificates and other regulatory documents.

Assist in checking product documentation such as MDA registration details, certificates, supplier documents, Letter of Authorization (LOA), IFU and other relevant documents.

Maintain an updated database/list of registered medical devices and regulatory status.

Assist in preparing documents required for MDA, GDPMD audits and regulatory inspections.

Liaise with internal departments such as Purchasing, Quotation, Sales and Logistics to ensure regulatory requirements are fulfilled.

Assist in responding to requests for regulatory documents from customers, suppliers and internal departments.

Ensure proper document control, filing and traceability of RA records.

Assist in monitoring changes or updates to relevant MDA/medical device regulatory requirements.

Perform other regulatory and administrative duties as assigned by the management.

Requirements:

Diploma / Degree in Medical Engineering, Biomedical Engineering, Medical Device, Science, Healthcare, Regulatory Affairs or related field.

Fresh graduates are encouraged to apply.

Experience in Medical Device Regulatory Affairs / MDA / GDPMD will be an advantage.

Good organisational and documentation skills.

Detail-oriented and able to maintain accurate records.

Good communication and interpersonal skills.

Proficient in Microsoft Office (Word, Excel, Outlook).

Able to work independently as well as in a team.

Willing to learn and take responsibility for regulatory documentation and compliance matters.

Preferred Skills:

Knowledge of Malaysia Medical Device Authority (MDA) requirements.

Basic understanding of Medical Device Act 2012 (Act 737).

Basic knowledge of GDPMD requirements.

Experience in regulatory documentation, product registration or document control.

• Job Type: Full-time
• Department:
• Regulatory Affairs (RA)

Pay: RM1,800.00 - RM2,300.00 per month

Benefits:

• Dental insurance
• Free parking
• Health insurance
• Maternity leave
• Parental leave
• Professional development

Work Location: In person