- Brisbane based candidates, or open to relocate. Permanent opportunity.
- Opportunity to be an integral part of an expanding global business.

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 creative 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.
- Robust 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

What's on Offer

- Competitive salary.
- Opportunity to work in a global organisation.
- Challenging and rewarding role in a permanent capacity.
- Chance to lead and influence quality and regulatory standards in a highly regulated manufacturing environment.

If you're passionate about quality assurance and regulatory excellence, this role is a fantastic opportunity to make a meaningful impact.

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📌 QA & Regulatory Lead - MedTech (Brisbane City)
🏢 Michael Page Australia
📍 Brisbane City