Genetic Signatures improves patient care and outcomes by developing innovative diagnostic technologies that simplify molecular pathology. We are an Australian-based manufacturer supplying leading pathology laboratories locally and globally, and we continue to grow our diverse, supportive and high-performing team.

We are seeking an experienced and strategic Head of Product Development to lead the end-to-end delivery of innovative diagnostic products. This onsite, full-time role (38 hours per week) is responsible for driving product development activities across research, assay development, and system integration, ensuring the successful progression of projects from concept through to verification, validation, regulatory submission, and commercial launch.

In this role you will be responsible for:

• Lead end-to-end product development planning and execution aligned to CTO-approved technology strategy.
• Oversee research, assay development, system integration and technical documentation activities.
• Manage priorities, resources, risks, timelines, budgets and cross-functional dependencies.
• Provide leadership to the Development Lead, Research Lead and System Integration Lead.
• Coordinate outsourced partners, vendors and technical service providers.
• Ensure development outputs support design control, verification, validation and regulatory requirements.
• Drive stakeholder alignment across Quality, Regulatory, PMO, Product Management, Production and Commercial teams.
• Promote a culture of scientific excellence, quality, accountability and continuous improvement.

To be successful, you will possess:

• Minimum 10 years’ experience in molecular diagnostics, IVD, biotechnology, medtech or regulated life sciences.
• At least 5 years’ leadership experience in product development, R&D, system integration or technical delivery.
• Experience within an ISO 13485-aligned or medical device environment.
• Strong knowledge of design control, risk management, verification and validation activities.
• Excellent stakeholder management, leadership, communication and decision-making skills.
• Experience supporting regulatory submissions, product launch readiness and post-market activities.

Qualifications & Experience:

• Postgraduate qualification (Honours, master’s or PhD) in a relevant scientific, engineering or technology discipline.
• Project Management certification (PMP, PRINCE2 or equivalent) advantageous.
• Experience presenting technical information to executives, board or external scientific audiences.

Genetic Signatures Ltd is committed to providing equal employment opportunities. We thrive on the diversity of thought that comes through our workforce and encourage anyone with talent and drive to better healthcare outcomes to apply.

If you are interested in applying for this role, please apply via Seek or send your resume and cover letter to [email protected].