Regulatory Affairs Engineer, Manufacturing Lifecycle

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 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.

• Help turn the handover from engineering into production into a controlled process that satisfies good manufacturing practice

requirements (design transfer).

• 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.

• Contribute as a regulatory affairs engineer to product-related regulatory activities where manufacturing and distribution are

involved.

• Work operationally and enjoy it, with success measured by correct shipment documentation and adherence to good manufacturing

practice on every device built.

• Understand regulatory obligations for medical device manufacturing, including incoming component controls, equipment

calibration and maintenance, manufacturing records, and device release records.

• Have three to five years of experience in quality or regulatory affairs for medical devices, with direct exposure to

manufacturing. Either background is suitable, but a strong understanding of regulatory requirements for device manufacturing is

essential.

• Possess working knowledge of ISO 13485, EU Regulation 2017/745 (MDR), and FDA 21 CFR Part 820, with particular emphasis on

production and process control as well as device release requirements.

• Familiar with the documentation required for exporting medical devices, including FDA import requirements and customs

documentation.

Neko designs and manufactures its own devices, so the distance between a design decision and a device coming off the line is short

and you will see both ends of it. You will work on design transfer while it is being built into a repeatable process, and you will

be the person the company relies on for how its devices reach the markets we ship to. Both have a direct, visible effect on what

gets delivered.

This role is based in Stockholm, Sweden, within close proximity to our manufacturing site. Regular on-site presence with the

production team is required, although some remote work is permitted. All manufacturing and shipments are carried out from Sweden.