Regulatory Affairs Engineering Lead - Heart Program

Neko Health; Stockholms kommun; On-site; SEK 550,000 - 800,000; Full time

Job summary

Neko Health in Stockholm is seeking a skilled regulatory affairs professional to join our team specializing in cardiological devices. The ideal candidate will have a strong background in regulatory compliance, particularly with EU MDR and FDA submissions, and will provide guidance throughout the product lifecycle.

We value analytical and communication skills and seek someone who can navigate complex regulatory landscapes effectively. A degree in law, medicine, or engineering is preferred. Fluency in English is essential, and proficiency in Swedish is an advantage.

Qualifications

• At least 3 years of professional experience in regulatory affairs or quality management for medical devices.
• Working knowledge of regulatory standards including EU Regulation 2017/745 (MDR).
• Experience with direct communication with authorities and Notified Bodies.

Responsibilities

• Provide regulatory guidance throughout the product lifecycle.
• Support regulatory strategies for cardiological devices and software.
• Prepare and maintain EU MDR Technical Documentation.

Skills

Regulatory affairs experience

Analytical skills

Strong writing and communication skills

Fluent in English

Knowledge of EU MDR

Education

BSc or MSc in law, medicine, pharmacy, engineering, or relevant scientific discipline

Tools

Regulatory submission tools

Visual Studio Code

Azure DevOps

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.

Role Purpose

We are seeking a regulatory affairs professional to work with our medical devices in our portfolio of cardiology devices and applications. Depending on experience, the position may be hired as either an RA Engineer or RA Engineering Lead, both reporting to the RA Manager. You will work closely with engineering, clinical, product and project management teams to support regulatory activities across the product lifecycle. The role covers both hardware devices and software as a medical device (SaMD), with strong focus on EU MDR technical documentation, FDA submissions, post-market activities and regulatory guidance during development.

This role is suited for someone who is hands‑on, comfortable working cross-functionally, and able to apply regulatory requirements pragmatically in a fast-moving development environment.

What You’ll Be Responsible For

• Provide regulatory guidance throughout the product lifecycle, from development to market launch.
• Support development and maintenance of regulatory strategies for cardiological devices and software, covering classification positions, intended use, and market entry sequencing.
• Prepare and maintain EU MDR Technical Documentation and other regulatory dossiers.
• Support FDA pre‑market submissions and product registrations in applicable markets.
• Assess the regulatory impact of design and process changes and support change control activities.
• Contribute to device labelling and traceability activities.
• Participate in risk management activities in line with ISO 14971.
• Support post‑market surveillance, PMCF, vigilance, CAPA, and complaint handling activities.
• Contribute to internal and external audits, including Notified Body audits.
• Collaborate with engineering, clinical, product, and quality teams on regulatory and compliance matters.

Minimum Qualifications

• BSc or MSc degree within law, medicine, pharmacy, engineering, or another relevant scientific discipline; or equivalent professional experience.
• At least 3 years of professional experience in regulatory affairs or quality management for medical devices.
• Working knowledge of EU Regulation 2017/745 (MDR), FDA 21 CFR (including QSR), UK MDR, ISO 13485, ISO 14971, IEC 60601‑1 series, IEC 62304, and other applicable standards.
• Experience with regulatory submissions and direct communication with authorities and Notified Bodies across international markets.
• Excellent analytical skills, able to interpret complex regulatory requirements and provide risk‑based, practical recommendations.
• Strong writing and communication skills; able to give clear direction to development teams and engage credibly with external stakeholders.
• Highly self‑motivated; able to manage multiple workstreams independently and with minimal supervision.
• Fluent in English (oral and written).

Preferred:

• Experience with cardiovascular, cardiac monitoring, or electrophysiology medical devices.
• Proficiency in Swedish.
• Comfortable using AI tools in day‑to‑day work, particularly tools such as Claude and Microsoft Copilot, to support research, drafting, and operational efficiency.
• Experience with tools such as Visual Studio Code and Azure DevOps.

About titles at Neko

We use a simplified internal title framework that prioritises clarity over hierarchy, so internal titles may differ from market‑facing role titles. Scope, impact and level of the role are fully aligned and will be clearly discussed throughout the process.

Equal Opportunity & Inclusion Statement

Neko Health is committed to inclusive hiring and member‑first care. We welcome candidates from all backgrounds and encourage you to request reasonable adjustments to support your application.