---
title: 'Regulatory Affairs Engineering Lead, Clinical Evaluation at Neko Health'
canonical: 'https://feeny.ai/job/regulatory-affairs-engineering-lead-clinical-evaluation-neko-health-stockholm-rmnzfp0ta289'
type: 'job'
last_seen: '2026-11-08'
---

# Regulatory Affairs Engineering Lead, Clinical Evaluation at Neko Health

- **Company:** [Neko Health](https://feeny.ai/companies/neko-health)
- **Location:** Stockholm, Sweden
- **Employment:** full-time
- **Work type:** hybrid
- **Posted:** 2026-09-21
- **Last confirmed live:** 2026-11-08
- **Apply:** https://jobs.ashbyhq.com/neko-health/a5c93613-13ef-498a-8958-58595c322116

## 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'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.

## What you'll do

- 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
- Assess the regulatory and clinical impact of device changes, hardware and software, and support change control
- Own post-market surveillance and post-market clinical follow-up from the clinical evidence side, including regulatory change monitoring and incident reporting
- Design and deliver regulatory and clinical evaluation training for process owners and product teams
- Support internal and external audits, including notified body and agency interactions

## What you bring

Must-have:

- You have personally authored clinical evaluation plans and reports, clinical investigation plans, or clinical study protocols for medical devices
- Medical device regulatory experience under EU MDR, and under at least one of FDA 21 CFR or UK MDR 2002
- Clinical evaluation methodology: MEDDEV 2.7/1 Rev 4 and current MDCG guidance
- Clinical investigation requirements under ISO 14155, applied to real studies
- Hands-on submission preparation, with the clinical documentation as your part of it
- 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
- A risk-based, proportionate approach to compliance, and the judgement to tell what needs regulating from what doesn't
- Fluent English
- BSc or MSc in engineering, or in another relevant scientific discipline

Nice to have:

- A research or clinical science background
- Post-market clinical follow-up and PMCF plans
- Wearables, imaging or screening devices, where the company generated its own clinical evidence
- ISO 14971 risk management and IEC 62366-1 usability applied in product development
- ISO 13485 quality management systems, and embedding regulatory requirements into QMS processes
- Mentoring colleagues on regulatory or clinical evaluation topics
- Experience inside a fast-growing health technology company
- Fluent Swedish

## Why join this team

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.

## 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)

## Other roles at Neko Health

- [Executive Assistant Lead, SE](https://feeny.ai/job/executive-assistant-lead-se-neko-health-stockholm-dhmpf944r4gm) — Stockholm, Sweden
- [Lead Program Manager](https://feeny.ai/job/lead-program-manager-neko-health-stockholm-03r6ashx54yb) — Stockholm, Sweden
- [Medical TA Lead](https://feeny.ai/job/medical-ta-lead-neko-health-new-york-gs9pbmxnm77b) — New York, NY
- [Family Medicine Physician](https://feeny.ai/job/family-medicine-physician-neko-health-miami-7xghg55er0y7) — Miami, FL
- [Physician](https://feeny.ai/job/physician-neko-health-miami-0cncf2wwvecp) — Miami, FL
- [Nurse Practitioner](https://feeny.ai/job/nurse-practitioner-neko-health-miami-yqddgxx21cdh) — Miami, FL
- [Nurse Practitioner](https://feeny.ai/job/nurse-practitioner-neko-health-washington-2dfedzz2enhm) — Washington, DC
- [Field Service Engineer](https://feeny.ai/job/field-service-engineer-neko-health-london-r80d8mtp4ejc) — London, United Kingdom
- [Principal Clinical Scientist, Medical Devices & AI](https://feeny.ai/job/principal-clinical-scientist-medical-devices-ai-neko-health-new-york-ye048s51gzqa) — New York, NY
- [Laboratory Technical Supervisor](https://feeny.ai/job/laboratory-technical-supervisor-neko-health-new-york-ns3kqabf7p86) — New York, NY