Regulatory Affairs Engineering Lead - Skin Program

Mission

Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives. Role Purpose

We are seeking a Regulatory Affairs professional to support our portfolio of dermatological medical devices and software applications. Depending on experience, the position may be hired as either an RA Engineer or RA Engineering Lead, both reporting to the RA Manager. You will work closely with engineering, clinical, product, and project management teams to support regulatory activities across the product lifecycle. The role covers both hardware devices and software as a medical device (SaMD), with a strong focus on EU MDR technical documentation, FDA submissions, post-market activities, and regulatory guidance during development. This role is suited for someone who is hands-on, comfortable working cross-functionally, and able to apply regulatory requirements pragmatically in a fast-moving development environment. What You’ll Deliver in the First 6–12 Months

· Establish full ownership of EU MDR Technical Documentation and regulatory dossiers for dermatological hardware and SaMD products in the Skin Program. · Support or lead at least one FDA premarket submission or CE marking activity, demonstrating end-to-end ownership of the submission process. · Become the primary regulatory contact for the Skin Program engineering, clinical, and product teams — embedded in design reviews and change control processes from day one. · Actively contribute to post-market surveillance, PMCF, vigilance, and complaint handling activities, ensuring all products remain in continuous compliance across their lifecycle.