Job Description

We are seeking a Regulatory Officer to manage and coordinate all activities related to medical device registration and compliance with the Medical Device Authority (MDA) requirements. The ideal candidate will ensure that all documentation, certifications, and renewals are properly managed, submitted, and maintained in compliance with GDPMD and relevant regulatory standards.

Key Responsibilities

Manage MDA product registration, including collecting documents from principals, preparing submissions, and liaising with certification bodies. Maintain proper records and systematic arrangement of MDA-related documents. Update and maintain the MDA Master List, ensuring timely renewal of product certifications and establishment licenses. Provide necessary supporting documents to relevant departments when requested. Evaluate all company products and provide recommendations for regulatory registration. Familiarize and comply with the GDPMD Regulatory Compliance Manual (RCM), ensuring all documents are properly maintained and recorded. Assist in internal and external audits related to GDPMD compliance.
Requirements

Degree or Diploma in a Science-related field (e.g., Nursing, Biomedical Science, Pharmacy, or equivalent). Experience in regulatory affairs is not required; training will be provided. Proficient in Microsoft Office and experienced in document organization and record management. Detail-oriented, responsible, and able to work independently with minimal supervision. Strong communication and coordination skills.
Why Join Us

Opportunity to gain hands-on experience in the medical device regulatory field. Supportive work environment with career development opportunities. Exposure to MDA registration, GDPMD compliance, and audit preparation processes.
Interested? Send your resume to hr@ophthalmic.com.my!

Job Types: Full-time, Permanent, Fresh graduate

Pay: RM2,500.00 - RM4,000.00 per month

Benefits:

Opportunities for promotion Professional development
Work Location: In person