- 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 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
- 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.
QA & Regulatory Lead - MedTech in Brisbane employer: Michael Page Australia
Join a leading HR consultancy that values your expertise and offers a dynamic work culture focused on collaboration and professional development. With competitive salaries, hybrid working options, and a commitment to employee growth, this role as a Senior HR Advisor in the industrial sector provides a meaningful opportunity to make a significant impact within a prominent industrial group.
