---
title: 'Regulatory Affairs Engineer, Post-Market Surveillance at Neko Health'
canonical: 'https://feeny.ai/job/regulatory-affairs-engineer-post-market-surveillance-neko-health-stockholm-bgyqp935ehwh'
type: 'job'
last_seen: '2026-11-08'
---

# Regulatory Affairs Engineer, Post-Market Surveillance 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/9213387e-8f80-4857-8c08-387bf18b8dcf

## 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 engineer to strengthen how Neko runs post-market surveillance across its device portfolio. 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.

## What you will be responsible for

- Run and maintain the post-market surveillance process across the device portfolio, applying it consistently from programme to programme.
- Put the PMS SOP into practice, keep it current, and propose updates as the process matures.
- Produce the periodic post-market trend reporting and the post-market literature searches, and establish a repeatable method for both.
- Prepare the post-market sections of technical documentation and the periodic reports delivered to Notified Bodies.
- Support the regulatory owners of individual devices on post-market questions, and become the reliable

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

- Are knowledgeable about post-market guidance and understand the current best practices for PMS activities, going beyond just regulatory requirements.
- Have hands-on experience with devices that have been available on the market for several years.
- Prefer creating repeatable processes and running them efficiently, rather than working on tasks individually.
- Collaborate easily across functions—post-market surveillance requires working with regulatory, quality, clinical, and engineering teams.
- Have experience managing post-market obligations across multiple risk classes and understand how these requirements differ.
- Enjoy optimizing work processes, especially streamlining and accelerating repetitive regulatory tasks.
- Excel under a manager who provides direction but allows you the autonomy to choose how to accomplish your work.

Background and experience

- 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)
- Medical device experience, with familiarity in MDCG guidances and post-market obligations specific to medical devices
- Working knowledge of EU Regulation 2017/745 (MDR) post-market requirements, applicable MDCG guidances, ISO 13485, and ISO 14971
- Experience contributing to periodic post-market reporting for a Notified Body
- Excellent analytical and writing skills, as much of the role's output is subject to audit
- Self-motivated and able to run a cross-programme workstream efficiently
- Fluent in English (oral and written)
- Comfortable using AI tools such as Claude for research, drafting, and operational efficiency
- Experience automating or streamlining regulatory workflows, including light scripting, is an advantage
- Experience with Visual Studio Code and Azure DevOps is an advantage

## Why this role Is unique

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.

## What we offer

- Cross-programme scope from day one, across the whole device portfolio rather than a single programme.
- Direct guidance from an experienced RA Engineering Lead, and room to grow into wider ownership.
- Close proximity to engineering, clinical, quality and product teams in a company that designs and builds its own devices.
- A small, experienced regulatory team where your judgement carries weight and your contributions are visible.
- Competitive salary and benefits package.

## 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