---
title: 'Regulatory Affairs Engineer, Manufacturing Lifecycle at Neko Health'
canonical: 'https://feeny.ai/job/regulatory-affairs-engineer-manufacturing-lifecycle-neko-health-stockholm-27cb3n4951a5'
type: 'job'
last_seen: '2026-11-08'
---

# Regulatory Affairs Engineer, Manufacturing Lifecycle at Neko Health

- **Company:** [Neko Health](https://feeny.ai/companies/neko-health)
- **Location:** Stockholm, Sweden
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-09-24
- **Last confirmed live:** 2026-11-08
- **Apply:** https://jobs.ashbyhq.com/neko-health/b097bbb1-f601-41c8-95f4-a7ce3ef4bfb4

## Job description

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.
- Work day-to-day with the production and manufacturing teams on site.
- Contribute as a regulatory affairs engineer to product-related regulatory activities where manufacturing and distribution are involved.

. Who will thrive in this role You are likely to thrive if you:

- 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 experience looking at manufacturing from the regulatory or quality side.
- Confident and experienced enough to collaborate with an established production team and advocate for needed changes.
- Prefer being physically present where devices are produced.
- Enjoy formalizing informal practices into documented and repeatable processes.

Background and experience

- Hold a BSc or MSc in engineering, a relevant scientific or technical discipline, or have equivalent professional experience.
- 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.
- Experienced in supporting design transfer or production process validation.
- Fluent in English (oral and written); knowledge of Swedish is a plus.
- Comfortable using AI tools, such as Claude, for research, drafting, and enhancing operational efficiency.
- Experience with Visual Studio Code and Azure DevOps is a plus.

What makes this role unique 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.

## What we offer

- A clearly defined area of work, end to end, in a company that builds its own hardware.
- Direct working relationships with production, engineering, and quality, on site rather than at a distance.
- Direct guidance from an experienced RA Engineering Lead, and room to grow into wider ownership.
- A small, experienced regulatory team where your judgement carries weight and your contributions are visible.
- Competitive salary and benefits package.

Location 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.

## About Neko Health

## Company Overview
- **One-liner**: Neko Health is a healthcare technology company that has engineered a proprietary, data-driven preventive health scan to detect early signs of disease in otherwise healthy individuals.
- **Entity Type**: Private (Funding Stage: Series A)
- **Headquarters**: Stockholm, Sweden
- **Founded**: 2018
- **Founders**: Daniel Ek (Co-founder, also founder/CEO of Spotify) and Hjalmar Nilsonne (Co-founder)

## Core Business
- Primary industry/industries: Healthcare Technology, Preventive Medicine, Clinical Diagnostics
- Target customers: B2C – Health-conscious individuals; B2B Potential – Self-insured employers
- Mission or purpose statement: “To provide healthcare that’s proactive instead of reactive – so that people can live longer, healthier lives.”

## Products & Services
- **[The Neko Health Scan]**: A 60-minute, full-body health check that captures millions of data points across the skin, heart, blood, and circulation using four proprietary devices (Derma, Spectrum, Echo, and Neko Lens). Includes an unrushed consultation with a doctor where results are discussed immediately. The scan is priced at approximately 2750kr (~$260) in Sweden and is designed for asymptomatic, healthy individuals looking for prevention.

## Market Standing
- **Valuation/Market Cap**: Not publicly disclosed (as of mid-2026).
- **Key Metric**: Total Funding – **$325.1M** (one prior funding round).
- **Notable Investors/Partners**: Backed by “investors who have built and scaled some of the most ambitious technology companies of the last two decades” (individual names not publicly listed on career page). The company has strong ties to the tech and startup ecosystem.
- **Growth Signals**: Over 1,000 employees (more than half in clinical roles). Aggressive expansion with active clinic locations in London, Manchester, Birmingham, Stockholm, and plans for more. Job postings have increased +344.4% year-over-year (as of mid-2026), indicating rapid scaling.

## Competitive Advantages
- **Proprietary Hardware**: All four scanning devices are designed, engineered, and assembled in-house in Stockholm, creating a hard-to-replicate technological moat.
- **Integrated Clinical Model**: Unlike traditional clinics or digital health apps, Neko combines its proprietary hardware with on-site doctors, clinical researchers, and data science under one roof with a low patient volume per doctor ( ~9 members/day vs. 30+ in standard care). This enables a focus on prevention, not just treatment.
- **Data Moat**: The system captures millions of structured data points per scan, allowing for peer benchmarking and longitudinal tracking over years, creating a powerful, network-effect dataset for preventive health insights.
- **Leadership**: Co-founded by Daniel Ek (Spotify) and Hjalmar Nilsonne.

## Strategic Focus
- **Scaling the Scan Room**: Neko is actively testing a second-generation modular scan room platform designed to capture more signals and scale to new locations.
- **Global Expansion**: Opening new clinics across the UK and Europe, with a clear intent to make the service more accessible.
- **Clinical Research & Governance**: Continued focus on validating their devices with clinical studies and building a clinical leadership team (including ex-NHS and Amazon Health executives) to establish preventive care as a formal clinical discipline.

## Why Work Here
- **Mission-Driven**: The company was founded to solve the fundamental problem of late-stage diagnosis by focusing on prevention. The work is presented as having a direct, positive impact on human longevity.
- **Culture & Engineering**: The company actively showcases a deep engineering culture where “clinical insight can become a hardware iteration overnight.” Clinicians and engineers share the same floor, fostering rapid iteration and innovation.
- **Compensation & Benefits**: Salaries are benchmarked via market research. Benefits include comprehensive Medical, Dental, and Vision Insurance, 401K, Paid Time Off, Life Insurance, Disability Insurance, CME Days, and Commuter Benefits.
- **Work Model**: Roles are **on-site** at specific clinic locations. Training for medical roles is fully paid. The interview process is designed to give candidates a feel for the culture and mission.
- **Growth Trajectory**: With 80+ active job postings and triple-digit growth in hiring, the company is in a high-growth phase, offering significant career development opportunities.

## Sources
1. [nekohealth.com](https://www.nekohealth.com/en)
2. [nekohealth.com](https://www.nekohealth.com/us/en/about)
3. [linkedin.com](https://www.linkedin.com/company/nekohealth)
4. [nekohealthcareers.com](https://www.nekohealthcareers.com/)
5. [jobs.ashbyhq.com](https://jobs.ashbyhq.com/neko-health)

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