Copenhagen or Melbourne ideally - Remote friendly

Overview

Are you passionate about healthcare, deep tech, and societal impact? Want to play a leading role as Hearables 3D grows from a profitable startup to an iconic scaleup? Excited by the prospect of leading regulatory affairs for a new AI CAD Automation software product? We are looking for an ambitious Regulatory Affairs Manager who gets energised by these questions!

About Hearables 3D

Hearables 3D is an Australian Ph.D. research spinout whose mission is to make custom-fit audio devices (e.g. hearing aids) accessible to everyday people. We do this by providing audio manufacturers software products – CAD Automation and Smartphone Scanning – to grow their custom-fit businesses.

Since our product launch in 2021, Hearables3D has partnered with industry leaders such as Logitech, Sennheiser, and Formlabs. The company is backed by leading investors such as Afterwork Ventures, Starfish Ventures, and Significant VC.

What You’ll Do

Outcomes you’ll deliver:

• Becoming regulatory compliant so that we can legally market our new software product. Initial target jurisdictions (and corresponding device classifications) include: (I) USA – Class II, 510k Exempt; (II) EU – class; (III) Australia – class 1

• Supporting the establishment and maintenance of a QMS that is compliant with relevant standards (e.g. ISO 62304)

• Build a world-class regulatory affairs team

Activities you’ll lead:

• Creation of relevant Technical Files – e.g. risk management, UDI, etc

• Managing external audits from regulatory and notified bodies

• Overseeing validation and testing activities

• Coordinating with relevant team members to implement the QMS

• Engaging with and managing contractors/agencies where needed

Who You Are

Must-have requirements:

• 2-5+ years relevant experience in regulatory affairs and/or QMS

• Able to work permanently full-time or part-time. No contracting

Nice-to-have requirements:

• Experience with products that have similar regulatory requirements – e.g. software as a medical device, Class II, 510k Exempt, etc

• Experience establishing new products (e.g. going from inception to market launch), not just maintaining compliance with existing products

• Lead and manage a regulatory affairs team

• Understands the audio CAD/CAM industries

• Worked in a post-Series A tech company, ideally in a remote SaaS company

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 family members, 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 Melbourne.

Apply Now

The recruitment agency Moving Talent is taking care of the recruitment process. Please contact Nathalie Dedella if you have further questions.