Global Head of Quality & Regulatory Affairs

A unique opportunity has arisen to join a high-growth global healthcare technology business undergoing significant regulatory and product expansion across international markets.

Reporting directly to the CEO, this role will lead the Quality & Regulatory function globally, partnering closely with Product, Engineering, Clinical and the executive team.

The role spans quality systems, regulatory strategy, clinical risk, submissions and post-market oversight within a modern software-led healthcare environment, with responsibility for clinical safety and regulatory release oversight across global markets.

Key responsibilities

• Leading the global Quality & Regulatory function across a growing regulated software environment
• Supporting and evolving the Quality Management System in line with TGA, ISO 13485 and broader international regulatory frameworks
• Leading regulatory submissions and product expansion activities across Australian and international markets, including exposure to FDA pathways
• Partnering closely with Product, Engineering and Clinical teams to help shape how regulated software products are designed, governed and released into market
• Setting and maintaining the regulatory and quality standards underpinning software development, product governance and clinical safety activities
• Supporting software lifecycle, risk management and post-market monitoring processes within a fast-moving technology environment
• Leading audit readiness activities and supporting regulator and external stakeholder engagement
• Contributing to the ongoing development of scalable regulatory and quality processes suited to a growing global business

About you

• Experience across quality systems, regulatory affairs and product or clinical risk management within a regulated healthcare, MedTech, SaMD or digital health environment
• Exposure to software-led healthcare products, clinical technologies or emerging technology environments
• Experience working with Australian and/or international regulatory frameworks, including TGA, ISO 13485 and ideally FDA or broader global pathways
• An ability to operate effectively across technical, product and business stakeholder groups
• A pragmatic and commercially minded approach suited to a scaling environment
• Exposure to international markets, software-based medical technologies or AI/ML-enabled healthcare products will be highly regarded.

This is an opportunity to help shape the future of healthcare technology within a genuinely mission-driven business operating at global scale.

If this opportunity is of interest, please click ‘Apply’ to submit your CV, or for further information or a confidential discussion, contact Aislyn Jennings, ***email_hidden***