26/02/2026
Regulatory Affairs Executive (Medical Device Industry)
We are seeking a highly motivated and detail-oriented Regulatory Affairs Executive to oversee medical device regulatory compliance, licensing, certification, and quality management system (QMS) requirements. Interested applicants can submit resume to hr@foresight.com.my or contact 017-2003156.
Key Responsibilities
• Prepare and submit medical device registration dossiers (CSDT) to the Medical Device Authority (MDA) in accordance with Malaysian regulatory requirements
• Manage new registrations, re-registrations, and change notifications to ensure timely approvals
• Monitor regulatory updates and ensure full compliance with applicable laws and guidelines
• Oversee company licensing and certification matters (business, manufacturing, and related approvals)
• Lead and coordinate internal and external audits in compliance with ISO 9001, ISO 13485, GDPMD, and ISO 14971
• Act as Management Representative (MR) during audits and report findings to Management
• Oversee risk management processes throughout the medical device lifecycle
Requirements
• Bachelor’s Degree in Pharmacy, Life Sciences, Biomedical Engineering, Regulatory Affairs, or related discipline
(Diploma holders with strong regulatory experience are encouraged to apply)
• Minimum 2–3 years of experience in regulatory affairs within medical device or pharmaceutical industry
• Hands-on experience in MDA submission and compliance documentation
• Strong knowledge of ISO 9001, ISO 13485, GDPMD, and ISO 14971
• Excellent written English and good communication skills in English & Bahasa Malaysia
• Highly organized, detail-oriented, and able to manage multiple regulatory timelines
