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QA & Regulatory Lead - MedTech

Brisbane Permanent AU$170,000 - AU$190,000 per year View Job Description
Looking for a hands on leader who can set up, strengthen, and potentially scale the quality and regulatory function of a medical device manufacturing operation, rather than simply maintain an existing system. Someone who can roll up their sleeves while also owning strategy and external regulatory relationships.
  • 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 between AUD $170,000 and AUD $190,000 plus super.
  • 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. Apply today to take the next step in your career!

Contact
Harley Logan
Quote job ref
JN-072026-7058528
Phone number

Job summary

Function
Engineering & Manufacturing
Specialisation
Quality, Technical
Industry
Industrial / Manufacturing
Location
Brisbane
Job Type
Permanent
Consultant name
Harley Logan
Consultant phone
Job Reference
JN-072026-7058528

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know. Michael Page acknowledge and pay our respects to the Traditional Custodians of the land we operate on.