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 cutting-edge 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
- Strong Experience in precision manufacturing

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