Regulatory Affairs Officer 2

Suria-Medik; Bandar; On-site; IDR 263,690,000 - 439,483,000; Full time

Job summary

Suria-Medik is seeking a meticulous Regulatory Affairs Officer to oversee regulatory activities for medical devices, ensuring submissions and documentation comply with MDA requirements. You will prepare registrations, maintain records, and liaise with authorities and suppliers in a dynamic environment.

Fresh graduates are welcome to apply, and you will monitor regulatory changes, assist audits, review labelling and declarations, and support licence renewals across cross-functional teams.

Qualifications

• Bachelor’s degree in biomedical, electronics, mechanical or electrical engineering or related field.
• Experience in medical device regulatory affairs / MDA registration is a plus.
• Good documentation and organisational skills.
• Fluent in English and Bahasa Malaysia.

Responsibilities

• Prepare, submit and monitor medical device registrations and regulatory applications.
• Manage regulatory documentation, records and product registration status.
• Ensure compliance with MDA and other regulatory authorities.
• Assist in applications and renewals of licences, permits and certificates.
• Liaise with MDA, suppliers, manufacturers and internal departments on regulatory matters.
• Review product documents such as certificates, technical documents, labelling, IFU and declarations of conformity.
• Maintain accurate and up‑to‑date regulatory files and databases.
• Monitor changes in regulatory requirements and advise the company accordingly.
• Support internal and external audits related to regulatory and quality requirements.
• Assist in the preparation of documents for ISO 13485 / GDPMD compliance.
• Perform other regulatory and administrative duties as assigned by management.

Skills

Communication skills

Detail-oriented

Organisational skills

Microsoft Office

Education

Bachelor’s Degree in Biomedical Engineering

Bachelor’s Degree in Electronics Engineering

Bachelor’s Degree in Mechanical Engineering

Bachelor’s Degree in Electrical Engineering

Tools

Microsoft Office

Job description

Jora Malaysia will close on 9th September 2026. Thank you for being with us, we are cheering you on as you continue your career journey.

Please do not apply to whom already applied for the same position.

Job Summary

• We are looking for a responsible and detail‑oriented Regulatory Affairs Officer to support and manage regulatory activities related to medical devices and healthcare products. The successful candidate will ensure that all regulatory submissions, registrations, licences and documentation comply with the requirements of the relevant authorities.Key ResponsibilitiesPrepare, submit and monitor medical device registration and regulatory applications.
• Manage regulatory documentation, records and product registration status.
• Ensure compliance with requirements from the Medical Device Authority (MDA) and other relevant regulatory authorities.
• Assist in applications and renewals of licences, permits and certificates.
• Liaise with MDA, suppliers, manufacturers and internal departments on regulatory matters.
• Review product documents such as certificates, technical documents, labelling, IFU and declarations of conformity.
• Maintain accurate and up‑to‑date regulatory files and databases.
• Monitor changes in regulatory requirements and advise the company accordingly.
• Support internal and external audits related to regulatory and quality requirements.
• Assist in the preparation of documents for ISO 13485 / GDPMD compliance.
• Perform other regulatory and administrative duties as assigned by management.

Requirements

• Bachelor’s Degree in Biomedical Engineering, Electronics Engineering, Mechanical Engineering, Electrical Engineering or related field. Fresh graduates are encouraged to apply.
• Experience in medical device regulatory affairs / MDA registration will be an added advantage.
• Good understanding of Malaysian medical device regulatory requirements is preferred.
• Good documentation and organisational skills.
• Detail‑oriented, responsible and able to work independently.
• Good communication skills in English and Bahasa Malaysia.
• Proficient in Microsoft Office applications.

What We Offer

• Competitive salary based on experience and qualifications.
• Training and career development opportunities.
• Opportunity to gain hands‑on experience in the medical device regulatory and quality management field.