Compliance and Operations Executive (Medical) - Kuala Lumpur

We are a growing prosthetics and orthotics company based in Malaysia, committed to delivering high-quality assistive solutions. We are seeking a proactive and detail-oriented Compliance & Operations Executive to join our team. This dual-role position will be responsible for ensuring compliance with the Medical Device Authority (MDA) regulations and supporting daily operations to enhance workflow, productivity, and service delivery.

• Manage all matters related to MDA registration, licensing, and renewals (establishment license, product registration, etc.).
• Prepare, submit, and maintain documentation required by the MDA and other relevant regulatory bodies.
• Serve as the main liaison with the MDA and ensure compliance with applicable Medical Device Act 2012 (Act 737) requirements.
• Monitor and update internal systems and teams on regulatory changes affecting the business.
• Assist with product traceability, adverse event reporting, and post-market surveillance processes

• Track and manage project timelines, client orders, and job progress using internal tools or spreadsheets.
• Identify inefficiencies in current processes and implement improvements for smoother operations.
• Coordinate between clinical, technical, and administrative teams to ensure timely service delivery.
• Support inventory management, scheduling, and procurement where necessary.
• Generate periodic reports on operations, compliance status, and performance metrics.

• Assist in the development of SOPs related to compliance and operations.
• Help maintain documentation for audits, internal reviews, and ISO or quality certifications if applicable.
• Support the team with ad hoc operational or regulatory tasks as required.
• Degree or diploma in Healthcare Management, Business Administration or related field
• Prior experience or strong understanding of MDA regulatory processes is highly preferred
• Experience in operations, compliance, or administrative roles (medical/healthcare industry) is a plus
• Excellent organizational and communication skills
• Proficient in Microsoft Office Suite, especially Excel
• Ability to work independently and handle multiple responsibilities