REGULATORY AFFAIRS OFFICER

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 Responsibilities
• Prepare, submit and monitor medical device registration and regulatory applications.
• Manage regulatory documentation, records and product registration status.
• Ensure compliance with requirements from 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.
• Supportive working environment.