About Our Client
We are proud to be representing a global MedTech company dedicated to advancing assisted reproductive technology (ART) and fertility care, as they seek to appoint a Site Director for their production facility in Brisbane.
Formed by bringing together several industry-leading reproductive health and laboratory technology businesses, Nexpring Health is a global leader in fertility and reproductive health technology, providing innovative solutions that support fertility clinics and healthcare professionals worldwide. With a commitment to improving patient outcomes through science, innovation, and collaboration, Nexpring Health is helping shape the future of reproductive medicine.
Job Description
Job Responsibilities:
Own and maintain the site Quality Management System (QMS)
Serve as site Regulatory lead
Interface with regulatory agencies, notified bodies, and auditors
Lead internal, and regulatory audits and maintain inspection readiness
Manage CAPA, nonconformance, deviation, and complaint systems




Oversee validation activities for processes and equipment
Track quality and regulatory KPIs (FPY, scrap, audit results)
Ensure labelling, traceability, and documentation compliance
Support new product introduction and regulatory submissions
Drive root cause analysis and continuous improvement initiatives
Develop and lead the Quality & Regulatory team
The Successful Applicant
Skills & Experience:
Bachelor's degree in Engineering, Quality, Regulatory, or related field (Master's preferred).
7-10 years in highly regulated device manufacturing with 3+ years in leadership roles.
Strong knowledge of global regulatory requirements
Experience with regulatory submissions and agency interactions
Expertise in CAPA, validation, and risk management
Strong leadership and communication skills
Robust Experience in precision manufacturing
#J-*****-Ljbffr

📌 Qa & Regulatory Lead - Medtech (Brisbane)
🏢 Michael Page
📍 Brisbane