Regulatory Affairs Engineer, Post-Market Surveillance

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.

This cross-programme role reports to the RA Engineering Lead. Neko already has a post-market surveillance system in place, and you

will be responsible for operating it, ensuring it is applied consistently across all devices, and driving its continuous

improvement. Your duties will include implementing the PMS SOP, producing periodic reports, and transforming an established

process into one that is increasingly systematic and efficient as the portfolio expands. While the RA Engineering Lead provides

overall direction and supports regulatory decisions, you will have autonomy in determining how the work is carried out.

In addition to post-market surveillance, you will serve as a regulatory affairs engineer for our products, contributing to

regulatory activities throughout the device lifecycle alongside the rest of the RA team. Depending on your experience, the

position may be offered as either Regulatory Affairs Engineer or RA Engineering Lead.

• Run and maintain the post-market surveillance process across the device portfolio, applying it consistently from programme to

programme.

• Produce the periodic post-market trend reporting and the post-market literature searches, and establish a repeatable method for

both.

• Are knowledgeable about post-market guidance and understand the current best practices for PMS activities, going beyond just

regulatory requirements.

• Collaborate easily across functions—post-market surveillance requires working with regulatory, quality, clinical, and

engineering teams.

• BSc or MSc in engineering, medicine, pharmacy, law or another relevant scientific discipline, or equivalent professional

experience

• At least 3 years in regulatory affairs or quality for medical devices, with a meaningful part of that time spent on post-market

activities (three to five years is the target)

Post-market surveillance at Neko is a process you get to shape while you run it, not a fixed machine you feed. Because the role is

cross-programme, you see the whole portfolio rather than one device. And because Neko designs and manufactures its own devices,

what comes back from the field reaches you directly and feeds into the next version of the product.