**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.
**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**
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.
**Position Description**:AHFP Regulatory Manager
**Applications Close**:Tuesday 20 May 2025, 11:55pm AEST
**Supporting a diverse workforce