QA/RA 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

The Opportunity

Planet Pharma is supporting a growing international medical technology organisation in the search for a Quality Assurance & Regulatory Affairs Director.

This is a business-critical leadership position with broad responsibility across Quality, Regulatory Affairs, Manufacturing Quality Oversight, and compliance activities within a highly regulated environment. Reporting directly to executive leadership, this individual will have significant influence over quality strategy, regulatory direction, operational excellence, and future product development initiatives.

The successful candidate will act as the organisation's quality and regulatory expert, ensuring products remain compliant across global markets while helping the business scale and navigate continued growth.

This is an excellent opportunity for a senior QA/RA professional who enjoys building systems, influencing strategy, leading audits, and partnering closely with both technical and executive teams.

Key Responsibilities

Quality Leadership

• Act as the senior Quality representative within the organisation.
• Maintain and continuously improve the Quality Management System (QMS) in line with ISO 13485 and applicable global regulations.
• Develop and enhance quality and regulatory processes across the business.
• Lead CAPA, change control, investigations, non-conformance management, and continuous improvement activities.
• Drive supplier and vendor quality performance.
• Ensure ongoing audit readiness and successfully manage internal, external, customer, certification, and regulatory inspections.
• Promote a culture of quality and compliance across all functions.

Manufacturing & Product Quality

• Partner closely with manufacturing and operations teams to improve product quality and production outcomes.
• Support quality validation activities and implementation of QA/QC processes.
• Review quality metrics, identify trends, and implement corrective actions where required.
• Develop and refine testing methodologies and quality controls.
• Provide final quality approval for product release activities.
• Maintain batch records and product quality documentation.

Regulatory Affairs

• Develop and execute global regulatory strategies supporting both existing products and future launches.
• Own regulatory compliance activities across multiple international markets.
• Act as the key regulatory point of contact internally and externally.
• Prepare, review, and submit regulatory submissions and responses to regulatory agencies.
• Lead interactions with regulatory authorities, Notified Bodies, auditors, and certification agencies.
• Review technical documentation, product development records, and regulatory submissions.
• Ensure ongoing compliance with evolving global regulatory requirements.
• Provide regulatory guidance to R&D, Operations, Commercial, and leadership teams.

Leadership & Business Partnership

• Mentor and develop quality and regulatory capability across the organisation.
• Work closely with Executive Leadership to support business growth and strategic objectives.
• Collaborate with cross-functional stakeholders across Supply Chain, Manufacturing, Product Development, Operations, and Commercial teams.
• Support integration of regulatory requirements into day-to-day business operations.

About You

• 10+ years' experience within Quality Assurance and Regulatory Affairs, including senior leadership responsibilities.
• Significant experience within medical devices, diagnostics, life sciences, healthcare technology, or regulated manufacturing environments.
• Deep knowledge of ISO 13485 and quality management system implementation and maintenance.
• Experience leading regulatory submissions and managing relationships with regulatory authorities and certification bodies.
• Strong understanding of risk management principles, including ISO 14971.
• Experience leading audits, inspections, CAPAs, change controls, and quality investigations.
• Knowledge of product development, verification and validation activities within regulated environments.
• Comfortable operating strategically while remaining hands-on when required.
• Excellent communication, leadership, stakeholder management, and problem-solving skills.