QA/RA DIRECTOR

Planet Pharma; Australia; À distance; AUD 180 000 - 240 000; Plein temps

Résumé du poste

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

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

QA leadership

RA leadership

ISO 13485

Regulatory submissions

CAPA & change control

Audit management

Cross-functional leadership

Quality systems

Formation

Bachelor's degree in Life Sciences

Master's in related field

Description du poste

QA/RA Director

Location: Australia,
Category: Clinical Development and Operations,
Salary: Apply for details,
Country: Australia,
Employment: Direct Hire/Perm,
Worksite: Remote

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.

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

Fraud Alert

Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs. The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.