Regulatory Affairs Engineer

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.

About the role

We are looking for a regulatory affairs or quality engineer to work on design transfer and on the regulatory compliance of manufacturing and distribution at Neko.

This role sits at the point where a finished design becomes a manufactured device. Day to day you will work on the transfer of products from engineering into production, on the good manufacturing practice requirements that apply once a device is being built, and on the documentation that has to be in place before a device can be released and shipped to the markets where we operate.

The work is hands-on and close to the factory floor: with the production team, in the records created when a device is built, and in the paperwork that has to be right before a shipment leaves. You will report to the RA Engineering Lead, who sets the priorities and supports you on the regulatory judgement calls.

Depending on experience, the position may be hired as either a Regulatory Affairs Engineer or an RA Engineering Lead.

What you'll do

• Help turn the handover from engineering into production into a controlled process that satisfies good manufacturing practice requirements (design transfer).

• Apply and maintain the regulatory requirements for the controls on components entering the manufacturing facility.

• Apply and maintain the regulatory requirements for calibration and maintenance of manufacturing equipment.

• Look after the manufacturing records created when a device is built, and the records required to release it.

• Prepare, and be accountable for, the documentation for shipments to other markets, particularly the US, including customs documentation and accompanying FDA documentation, prepared for each individual shipment.

• Coordinate each shipment with production, ensuring that what Neko declares to the FDA is prepared by regulatory affairs.

• Monitor good manufacturing practice across the devices we build, and raise and follow up on any gaps found.