Position Title: Director Regulatory Affairs

Location: Brisbane, Queensland, Australia

Function: Science

Reporting to: Chief Scientific Officer

Role Overview

Join Microba, a pioneering diagnostics company shaping the future of healthcare through microbiome science. As the Director of Regulatory Affairs, you’ll lead the regulatory strategy and ensure compliance across multiple regions, including Australia, the US, UK, and EU. You will guide our innovative diagnostic products from development to approval, working closely with R&D, Quality, Product, and other teams to ensure they meet global standards.

Role Responsibilities

• Develop and implement regulatory strategies across all product phases.

• Oversee submissions, regulatory documentation, and compliance to meet local and international standards.

• Collaborate with cross-functional teams to ensure alignment with development and market entry timelines.

• Lead regulatory assessments, risk analysis, and manage responses to agency queries.

• Act as the company’s representative to regulatory authorities and external stakeholders.

Skills and Experience

• Bachelor’s or advanced degree in Life Sciences or a related field.

• 5–10 years of regulatory experience in diagnostics or medical devices, with leadership experience.

• Demonstrated success in managing global regulatory submissions and understanding regulatory frameworks, such as ISO 15189, and CLIA.

• Excellent communication and project management skills, with the ability to lead teams and influence stakeholders.

To Apply

How to Apply: Please submit your resume and cover letter online by clicking “apply”.

We review applications as we receive them. If your application is shortlisted, you will receive further information, which may include a Position Description.

Diversity & Inclusion

At Microba, we are committed to diversity and inclusion. We provide equal employment opportunities to all. We actively recruit and retain a diverse workforce and continuously improve our policies to foster a culture of diversity, equity, and inclusion.

Eligibility to work in Australia

Applicants for our job opportunities must have the legal right to work in Australia. We comply with all relevant laws and regulations related to employment eligibility verification and require all new hires to provide proof of their eligibility to work in Australia. This role requires the successful candidate to undertake a pre-screening police and identity check.

Microba overview

Microba is a Brisbane-based ASX-listed company with world-leading technology in the human gut microbiome. We have an ambitious and exciting vision to create a world where human health is transformed by microbiome science. The Group is rapidly expanding globally and delivers its microbiome testing services to consumers, healthcare practitioners, and researchers and is leveraging its leading microbiome database to discover and develop new microbiome-based treatments for some of the world’s most prominent unmet chronic diseases. At Microba, we utilise our world-leading gut microbiome technology, data, and team to positively impact millions of lives globally.

Working for Microba

Working at Microba means being part of the cutting-edge biotechnology industry. A successful candidate will have an opportunity to directly impact Microba and the global community by contributing to product excellence, efficacious therapy, and scalable revenue growth, helping Microba achieve its company strategy and annual objectives.

The benefits of joining the Microba team

• Ongoing Training and Development

• Health and Wellbeing focus

• Industry immersion

• Social Connection

• Community Contribution

• Employee Feedback

• Employee Assistance Program

Join us for a rewarding experience that values your well-being and growth.

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