Regulatory Manager -  Artificial Heart Frontiers Program

Job No.: 679406

Location: Brisbane, Queensland University of Technology

Employment Type: Full-time 

Duration: 3-year fixed-term appointment

Remuneration: $135,417 - $143,738 pa HEW Level 09 (plus 17% employer superannuation)

• Amplify your impact at a world top 50 University
• Join our inclusive, collaborative community
• Be surrounded by extraordinary ideas - and the people who discover them

The Opportunity

Are you ready to lead the regulatory strategy behind one of the most advanced developments in mechanical circulatory support (MCS) technologies?

The Artificial Heart Frontiers Program (AHFP) is seeking a Regulatory Manager to drive global regulatory strategy, compliance, and quality assurance for the development of cutting-edge Class III medical devices. You will play a critical leadership role at the intersection of innovation and patient care, collaborating with project teams, international experts, and key stakeholders to guide our lifesaving technologies toward successful market approval in the US, EU, APAC, and beyond.

What You’ll Do:

• Lead regulatory strategy from design through submission and approval for complex MCS device development projects.
• Manage global regulatory submissions and compliance activities aligned with ISO 13485, ISO 14971, FDA, MDR, TGA, and more.
• Implement and oversee a compliant Quality Management System (QMS) tailored to MCS devices.
• Serve as primary liaison with global regulatory bodies and consultants.
• Supervise external regulatory consultants to ensure excellence in project execution.

What We’re Looking For:

• Postgraduate qualifications or proven success in regulatory affairs, especially for Class III medical devices.
• Expertise in international medical device regulations (FDA, MDR, TGA, etc.).
• Strong project management and strategic leadership in regulatory contexts.
• Experience overseeing submissions in multiple markets with a track record of successful approvals.
• Outstanding communication, stakeholder management, and analytical skills.

Why AHFP?

You’ll be part of a pioneering team at the forefront of cardiovascular technology—contributing to innovations that save and improve lives. This role offers the chance to shape the future of medical device regulation and commercialization within a dynamic, research-led environment.

Be the regulatory force behind the future of artificial heart technology. Apply now and help us bring world-class medical devices to market.

About Monash University

At Monash, work feels different. There’s a sense of belonging, from contributing to something groundbreaking – a place where great things happen.

We value difference and diversity, and welcome and celebrate everyone's contributions, lived experience and expertise. That’s why we champion an inclusive and respectful workplace culture where everyone is supported to succeed.

Learn more about Monash.

Be part of our story. Work with us to #ChangeIt.

Monash supports flexible and hybrid working arrangements. We have a range of policies in place enabling staff to combine work and personal commitments. This includes supporting parents.

To Apply

For instructions on how to apply, please refer to 'How to apply for Monash Jobs'. Your application must address the Key Selection Criteria.

Diversity is one of our greatest strengths at Monash. We encourage applications from Aboriginal and Torres Strait Islander people, culturally and linguistically diverse people, people with disabilities, neurodivergent people, and people of all genders, sexualities, and age groups.

We are committed to fostering an inclusive and accessible recruitment process at Monash. If you need any reasonable adjustments, please contact us at hr-recruitment@monash.edu in an email titled 'Reasonable Adjustments Request' for a confidential discussion.

Your employment is contingent upon the satisfactory completion of all pre-employment and/or background checks required for the role, as determined by the University.

Enquiries: Carolyn Stone, AHFP Head of Operations, e: carolyn.stone@monash.edu

Position Description: AHFP Regulatory Manager

Applications Close: Tuesday 20 May 2025, 11:55pm AEST