ISO Consultant – Healthcare & Medical Devices

Role Overview

Vietnam's healthcare and medical device sector is undergoing rapid modernization, driven by government investment, international partnerships, and growing domestic demand for quality healthcare services. UPLYFT360° Vietnam is seeking a specialist ISO Consultant for our Healthcare & Medical Devices practice — supporting hospitals, clinics, medical laboratories, medical device manufacturers, and testing and calibration laboratories in achieving internationally recognized quality management certifications.

Key Responsibilities

• Lead ISO 13485 Medical Devices Quality Management System implementation projects
• Support medical and clinical laboratories in achieving ISO 15189 accreditation
• Guide testing and calibration laboratories through ISO/IEC 17025 accreditation preparation
• Develop quality management documentation tailored to healthcare and medical regulatory requirements
• Conduct training on ISO 13485, ISO 15189, and ISO/IEC 17025 requirements for healthcare professionals
• Perform internal audits and gap assessments against applicable standards
• Advise on Vietnamese regulatory requirements for medical devices (Ministry of Health circulars)
• Support validation and verification activities for medical device manufacturing clients
• Coordinate with accredited certification and accreditation bodies for assessment scheduling

Requirements

• 1 Minimum 3 years of experience in healthcare quality consulting or healthcare quality management
• 2 ISO 13485 Lead Auditor or equivalent certification
• 3 Working knowledge of ISO 15189 and ISO/IEC 17025 requirements
• 4 Understanding of Vietnamese Ministry of Health regulatory requirements for medical devices and healthcare
• 5 Fluent Vietnamese and proficient English
• 6 Healthcare, medical, pharmacy, or life sciences educational background preferred
• 7 Strong attention to detail and documentation discipline

Preferred Qualifications

• Experience with GMP for pharmaceutical or medical device manufacturing
• Familiarity with CE marking or FDA 510(k) regulatory pathways
• ISO 17025 Lead Assessor qualification
• Clinical laboratory or hospital quality management background

What We Offer

• Attractive salary package with healthcare specialist premium
• Sponsorship for ISO 13485 Lead Auditor certification
• Opportunity to work with Vietnam's leading hospitals, clinics, and medical device companies
• Continuous professional development in a rapidly evolving specialist field
• Contribution to improving healthcare quality standards across Vietnam