Global QA & Regulatory Director

Planet Pharma; Sydney; On-site; AUD 180,000 - 280,000; Full time

Job summary

Planet Pharma is seeking a highly experienced Quality Assurance & Regulatory Affairs Director to lead the global QA/RA function in a growing international medical technology organisation. You will own quality strategy, regulatory direction, and compliance across multiple markets, partnering with executive teams to scale the business.

The role oversees QMS maintenance, CAPA, audits, and regulatory submissions, while mentoring teams and shaping future product development initiatives.

Qualifications

• 10+ years of experience in Quality Assurance and Regulatory Affairs, including senior leadership responsibilities.
• Extensive experience in medical devices, diagnostics, life sciences, or regulated manufacturing environments.
• Deep knowledge of ISO 13485 and QMS implementation and maintenance.
• Experience leading regulatory submissions and managing relationships with authorities and certification bodies.
• Strong understanding of risk management principles, including ISO 14971.
• Experience leading audits, inspections, CAPAs, change controls, and investigations.

Responsibilities

• Act as the senior Quality representative within the organisation.
• Maintain and improve the QMS in line with ISO 13485 and global regulations.
• Develop and enhance quality and regulatory processes across the business.
• Lead CAPA, change control, investigations, non-conformance management, and continuous improvement.
• Drive supplier and vendor quality performance.
• Ensure ongoing audit readiness and manage inspections.
• Promote a culture of quality and compliance across all functions.
• Partner with manufacturing and operations to improve product quality and outcomes.
• Develop and execute global regulatory strategies for existing products and launches.
• Own regulatory compliance across international markets and liaise with authorities and bodies.
• Provide regulatory guidance to R&D, Operations, and Leadership.

Skills

Leadership

Stakeholder management

Communication

Problem solving

Risk management

Job description

Planet Pharma is seeking a highly experienced Quality Assurance & Regulatory Affairs Director to lead the global QA/RA function in a growing international medical technology organisation. You will own quality strategy, regulatory direction, and compliance across multiple markets, partnering with executive teams to scale the business.

The role oversees QMS maintenance, CAPA, audits, and regulatory submissions, while mentoring teams and shaping future product development initiatives.