Overview

Are you an experienced RA specialist who is passionate about healthcare, deep-tech, and positive societal impact? Fascinated by 3D, cloud and machine learning? Love working with cutting-edge tools, on a blank canvas, and in unconstrained environments? Want to play a leading role as H3D grows from a profitable startup to an iconic scaleup?

We are looking for an ambitious Regulatory Affairs Officer who gets excited by these questions! You will report directly to the Director of Engineering and shape the DNA of our company.

About H3D

H3D is an Australian Ph.D. research spinout whose mission is to make custom-fit devices (e.g. hearing aids, dental appliances) accessible to everyday people. We do this by providing AI technology to audio and dental labs – our Dental CAD, Audio CAD and Smartphone Scanning products – to grow their businesses and better support patients.

Since our product launch in 2021, H3D are growing fast and working with industry leaders such as Logitech, GN Resound, Modern Dental Group and many others. The company is backed by leading VC investors and has customers based worldwide.

What You’ll Do 

• Drive regulatory strategy and execution for dental software products, with a strong focus on EU MDR and AUS TGA compliance and emerging US FDA readiness

• Collaborate with software, product, and quality teams to integrate regulatory and cybersecurity standards into development and release cycles.

• Own and maintain technical documentation, clinical evaluations, and post-market surveillance in line with ISO 13485 and regional regulations.

• Advise on data protection and security frameworks, with a focus on ISO 27001 compliance.

• Support US market readiness by contributing regulatory insights aligned with FDA.

Must-Have:

• 3+ years of experience in regulatory affairs for medical devices or dental software, with proven expertise in EU (MDR), and preferably Australian (TGA), regulatory landscapes.

• Strong understanding of software as a medical device (SaMD) and applicable standards (ISO 13485, ISO 14971, IEC 62304, ISO 27001).

• Experience preparing and maintaining regulatory documentation, including technical files and post-market surveillance plans.

• Familiarity with FDA medical device regulations (21 CFR Part 820, 510(k), etc.).

• Self-driven and decisive, with strong communication skills and the ability to collaborate across engineering, quality, and leadership teams.

Nice-to-Have:

• Experience working with Class I/IIa/IIb medical devices within digital dental manufacturing.

• Prior involvement in regulatory audits, notified body interactions, or TGA submissions.

• Exposure to risk management, clinical evaluation reporting, and UDI requirements.

• Background in a startup or small company environment, balancing regulatory rigor with agility.

• Experience with data privacy regulations relevant to medical software (e.g., GDPR, HIPAA).

Our Culture

• Mission Driven: we value the social impact our work drives.

• Balanced + Fun Loving: we value our lives outside of work, as we’re a collective of dedicated gamers, surfers, rock climbers, musicians, travellers, and more.

• Quick Movers: we value getting things done, with a bias for action.

• Autonomy and Empowerment: we value independence and ownership.

• Embrace Challenges: we value resourcefulness, facing ambiguity with comfort.

The Benefits

Impactful Work: your work will benefit patients and humanity at large, and you will gain a unique career experience.

Generous Remuneration: we value working with the best, and we remunerate accordingly. This includes valuable equity options.

Remote First + Flexible: we enjoy the liberty of living where we want and working when we want, with teammates spanning Ireland, Denmark, Ukraine, France, and Australia.