Regulatory Affairs Engineering Lead, Clinical Evaluation

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.

We're looking for a regulatory affairs engineer to own the clinical side of Neko's regulatory work. You'd write the clinical

evaluation plans and reports, and the clinical documentation behind our submissions to the FDA, the EU and the UK.

Neko generates its own clinical evidence, so this is authored work. You'd plan and support clinical studies and investigations

under ISO 14155, appraise the literature and the clinical data behind each claim, and keep the clinical evaluation current as the

devices change.

It's hands-on and it runs across both hardware and software, working closely with the engineering, clinical and quality teams.

You'd join a small regulatory team where the other engineers come from hardware and software backgrounds, which is why this role

leans clinical.

• Write clinical evaluation plans and clinical evaluation reports under EU MDR Annexes XIV and XV, including the literature

review and the appraisal of clinical data behind them

• Own the regulatory side of clinical studies and clinical investigations, from study design input through to clinical

investigation submissions, under ISO 14155, UK MDR 2002 and FDA 21 CFR

• Build the regulatory strategy for clinical evidence across EU MDR, FDA and UK MDR, and turn it into a prioritised roadmap the

engineering and product teams can work to

• Prepare submissions and maintain the clinical sections of technical files, pulling together engineering, clinical and quality

input for notified body or agency review

• Give regulatory guidance to the hardware and software teams on IEC 62304, IEC 60601-1 and IEC 62366-1, so those requirements

are part of how the devices get built

• Own post-market surveillance and post-market clinical follow-up from the clinical evidence side, including regulatory change

monitoring and incident reporting

• You have personally authored clinical evaluation plans and reports, clinical investigation plans, or clinical study protocols

for medical devices

• Comfortable across hardware and software regulatory requirements, including IEC 62304, IEC 60601-1 and IEC 62366-1, and able to

turn them into guidance an engineer can act on

The clinical evidence behind a Neko scan is generated here, so the documents you write are the argument for what the product is

allowed to tell someone about their own health. You'd own that argument across the FDA, the EU and the UK.

The regulatory team is small and sits next to the engineers building the devices, so a question about what the evidence can

support gets answered in a conversation. You'd be the first person here whose weight is on the clinical and study side.