Regulatory Affairs Associate

Mandarin Opto-Medic Sdn Bhd; Puchong; On-site; MYR 100,000 - 150,000; Full time

Job summary

A medical device company located in Puchong is seeking a qualified individual to manage registration documents for MDA submission and ensure compliance with local regulations. Responsibilities also include monitoring certificate renewals and assisting in audits. Candidates with a degree in Science or Engineering are encouraged to apply, and fresh graduates are welcomed as training will be provided. Strong computer skills and proficiency in English and Malay are essential for this role.

Qualifications

• Degree in Science or Engineering related discipline is required.
• Proficient in using Microsoft Office and other file sharing tools.
• Ability to communicate in both English and Malay.

Responsibilities

• Check and compile registration documents for MDA submission.
• Monitor MDA certificate expiry and ensure re‑registration is completed.
• Assist in adverse event reporting.
• Ensure company compliance with local regulations.
• Prepare and conduct GDPMD audits.
• Register machine with JKKP and monitor CF expiry date.
• Assist in preparing quotation and tender.

Skills

Computer literacy, such as Microsoft Office

Able to read and write in English and Malay

Meticulousness

Education

Degree in Science or Engineering

Tools

Google Drive

Dropbox

WeTransfer

Job description

Responsibilities

• Check and compile registration documents for Medical Device Authority (MDA) submission.
• Monitor MDA certificate expiry date and ensure the re‑registration is completed before it expires.
• Assist in adverse event reporting.
• Ensure company compliance with local regulations.
• Prepare and conduct GDPMD internal audit and external audit.
• Register machine with JKKP and monitor the certificate of fitness (CF) expiry date for renewal.
• Assist in preparing quotation and tender.

Qualifications

• Degree in Science or Engineering related discipline.
• Computer literacy, such as Microsoft Office and file sharing tools (Google Drive, Dropbox, WeTransfer).
• Able to read and write in English and Malay language.
• Meticulous, initiative in reporting.
• Fresh graduates are welcomed, training will be provided.