Remote QA/RA Director – Medical Devices

Planet Pharma; Australia; Remoto; AUD 180.000 - 240.000; Tempo integral

Resumo da vaga

Planet Pharma is seeking a Quality Assurance & Regulatory Affairs Director to lead QA/RA across the organisation in Australia. The role oversees QMS, ISO 13485 compliance, regulatory strategy, and audits, partnering with manufacturing, R&D and operations to drive quality and compliance.

Reporting to executive leadership, you will shape quality systems, manage CAPAs, and coordinate global regulatory submissions while guiding senior teams through audits and inspections to enable growth in

Qualificações

• Senior leadership experience in QA/RA within regulated medical environments.
• Deep knowledge of ISO 13485 and medical device regulatory requirements.
• Experience leading regulatory submissions and audits globally.

Responsabilidades

• Lead the Quality Management System and drive ISO 13485 compliance.
• Develop and execute global regulatory strategies across markets.
• Own CAPA, change control, investigations, and non-conformance management.
• Lead audits and inspections with internal teams and external bodies.
• Collaborate with Manufacturing, R&D, Operations and leadership.
• Mentor quality and regulatory capability across the organisation.

Conhecimentos

QA leadership

RA leadership

ISO 13485

Regulatory submissions

CAPA & change control

Audit management

Cross-functional leadership

Quality systems

Formação

Bachelor's degree in Life Sciences

Master's in related field

Descrição da vaga

Planet Pharma is seeking a Quality Assurance & Regulatory Affairs Director to lead QA/RA across the organisation in Australia. The role oversees QMS, ISO 13485 compliance, regulatory strategy, and audits, partnering with manufacturing, R&D and operations to drive quality and compliance.

Reporting to executive leadership, you will shape quality systems, manage CAPAs, and coordinate global regulatory submissions while guiding senior teams through audits and inspections to enable growth in