REGULATORY AFFAIRS LEAD, APAC & EMEA

Join a mission-driven company at the forefront of infection prevention and medical device innovation. At Nanosonics, we don’t just create products — we challenge conventions to protect patients, clinics, and communities around the world.

We are currently seeking a Regulatory Affairs Lead – APAC & EMEA to join our Global Regulatory Affairs team. In this pivotal role, you will take ownership of regulatory strategies and operational execution across the APAC and EMEA regions, enabling timely market access and sustained compliance of Nanosonics’ products. This is a unique opportunity to shape regulatory outcomes across diverse, high-impact markets.

Key Responsibilities:

• Lead and coordinate product registrations, renewals, and end-of-life de-registrations for APAC & EMEA markets.
• Ensure compliance with post-market regulatory requirements, directly or via in-market representatives.
• Partner with commercial and marketing teams to provide regulatory support for tenders, market entry proposals, and other sales-enabling initiatives.
• Prepare for and support regulatory agency and certification audits.
• Act as a regulatory subject matter expert to ensure awareness and integration of regional requirements across the business.
• Review and approve promotional and marketing materials for compliance in relevant markets.
• Drive continuous improvement in regulatory processes and systems.
• Ensure adherence to Nanosonics’ Quality Management System and evolving global regulatory standards.

What You’ll Bring:

Qualifications & Experience:

• Tertiary qualifications in Regulatory Affairs, Engineering, Science or a related discipline.
• Minimum of 5 years’ experience working with medical device regulations across APAC and/or EMEA markets.
• Strong understanding of country-specific regulatory landscapes and frameworks.
• Proven ability to manage multiple projects and competing priorities in a dynamic, fast-paced environment.
• Proficient in Microsoft Office tools.

Skills & Attributes:

• Strong initiative and ability to work autonomously.
• Detail-oriented with excellent written communication skills.
• Collaborative team player with excellent interpersonal and influencing skills.
• Innovative, solution-focused mindset with a continuous improvement orientation.
• Responsive, flexible, and business-savvy.

Why Nanosonics?

At Nanosonics, we are united by purpose and driven by innovation. You’ll work alongside passionate and highly skilled professionals in a values-led environment that encourages growth, creativity, and diversity. We invest in our people, offering a flexible, supportive workplace and the opportunity to make a real global impact.

Ready to make a difference?
Apply now to be part of a globally respected medical device company redefining standards in infection prevention.