Head of Quality and Regulatory Affairs

Biotech Recruitment Consultants

Perth WA (Hybrid)

Pharmaceuticals and Medical Devices (Healthcare and Medical)

Full time

Quality Management System

Regulatory Affairs

Regulatory Strategy

Help bring an innovative Australian medical technology from regulatory clearance through clinical development and commercial readiness.

About The Company: Our client is an Australian medical technology company developing medical devices using a novel biomaterial.

The company is entering an exciting stage of growth as they progress their first US FDA 510(k), implement an electronic Quality Management System (eQMS), and prepare for first-in-human clinical studies, whilst strengthening their manufacturing and commercial capabilities.

The company is seeking an experienced Head of Quality and Regulatory Affairs to lead their quality and regulatory function through this next stage of development.

The opportunity

Reporting directly to the CEO, you will have responsibility for the company’s quality and regulatory strategy while remaining hands-on in the preparation and review of regulatory submissions, technical documentation and quality systems.

This is a broad role suited to an experienced medical-device quality and regulatory professional who enjoys working in an emerging medtech environment and wants the opportunity to make a significant impact.

Whilst full-time is preferred, the company is open to considering part time (e.g. school hours or a four-day working week) for the right candidate, providing flexibility while retaining the seniority, scope and impact of the role.

You will work closely with our executive team, scientists, engineers, clinicians, manufacturing team and external regulatory and technical specialists.

Key responsibilities

You will:

Lead the company's regulatory strategy and submissions, including the FDA 510(k) submission and ongoing FDA interactions.

Lead the preparation and review of regulatory responses and submission documentation.

Drive implementation and continuous improvement of the company's QMS, including an electronic QMS.

Maintain and strengthen quality systems aligned with ISO 13485, ISO 14971 and applicable FDA and Australian medical-device requirements.

Provide quality and regulatory oversight across product development, design controls, risk management, verification and validation.

Review technical evidence supporting regulatory submissions, including performance, biocompatibility,



chemical characterisation, sterilisation, packaging and stability studies.

Assess the regulatory impact of product, material, manufacturing, packaging and process changes.

Oversee and work effectively with external laboratories, suppliers, regulatory consultants and specialist service providers.

Support manufacturing scale-up, validation and product-release readiness.

Lead quality and regulatory readiness for first-in-human clinical studies in Australia.

Build internal quality and regulatory capability and provide leadership and support to the QA team.

Provide clear quality and regulatory advice to the CEO, executive team and Board.

About you

We are looking for someone who combines strong medical-device regulatory and quality experience with a practical and solutions-focused approach.

You will ideally have:

A tertiary qualification in science, engineering, pharmacy, biomedical science, quality, regulatory affairs or a related discipline.

Significant experience in quality assurance and regulatory affairs within the medical-device industry.

Demonstrated experience with FDA 510(k) submissions, including deficiency or Additional Information responses and FDA interactions.

Strong working knowledge of ISO 13485, ISO 14971, medical-device design controls and FDA quality-system requirements.

Experience implementing, improving or scaling a QMS.

Experience reviewing technical and scientific evidence supporting medical-device regulatory submissions.

Strong technical writing and document-review skills.

Experience working with external laboratories, suppliers, consultants and other service providers.

Strong stakeholder-management skills and the confidence to constructively challenge evidence and decisions.

The ability to manage multiple priorities and critical work streams against regulatory deadlines.

Highly regarded

Experience in any of the following would be advantageous:

Implantable, resorbable, orthopaedic or biomaterial medical devices.

First-in-human or other medical-device clinical studies.

Australian TGA and clinical-trial pathways.

GLP studies or GMP manufacturing.





Biocompatibility and chemical characterisation.

Sterilisation, packaging validation and shelf-life/stability programs.

FDA, MDSAP or ISO 13485 audits and inspections.

What we're looking for in you

You will be hands-on, pragmatic and outcomes-focused, with the ability to move comfortably between regulatory strategy and detailed technical review.

You will be scientifically rigorous and evidence-led, with strong judgement and a commitment to patient safety and data integrity.

You enjoy working collaboratively in a growing organisation where systems and processes are continuing to evolve and where your expertise can directly influence how the company develops.

Why this Role?

This is an opportunity to join an Australian med tech company at a pivotal stage and play a key role in bringing an innovative technology toward patients and international markets.

In this role, you will have the opportunity to:

Lead quality and regulatory activities as the product progresses through FDA clearance, clinical development and commercial readiness.

Work directly with the CEO and a multidisciplinary team of scientists, clinicians, engineers and industry specialists.

Shape and build quality and regulatory systems rather than simply maintain established processes.

Build internal quality and regulatory capability as the company grows.

The position is based in Perth, Western Australia, with regular travel within Western Australia and occasional interstate or international travel as required.

Interested?

If you are an experienced medical-device quality and regulatory professional looking for a role where your expertise can have a direct impact on the development and commercialization of an innovative medical technology, we would like to hear from you.

If you are interested in a new and exciting career move and you feel you meet the requirements for the role so that we can arrange a confidential discussion about this role.

About Biotech Recruitment Consultants

Biotech Recruitment Consultants is a niche recruitment company specializing in executive search and recruitment for the broader biotechnology industry (including pharma, med tech, biologics, etc.).

We recruit for biotech, life science and healthcare roles worldwide and aim to provide personalized service for both clients and candidates.

Posted: 18-09-2026

Salary: Attractive package will be offered to right candidate

📌 Head of Quality and Regulatory Affairs (Perth)
🏢 Biotech Recruitment Consultants
📍 Perth