Senior Regulatory Affairs Engineer (TCI)

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.

Are you ready to shape the future of medical technology? Neko Health is seeking a Senior Regulatory Affairs Engineerwho’s passionate about tackling complex regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborativeand distributed environment. 

We are looking for you that have extensive experience from working with active medical devices and software as a medical device throughout the product lifecycle. 

What You’ll Do

• Drive Regulatory Excellence: Ensure our cutting-edge medical devices meet global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market. 

• Support Product Development: Advise on regulatory strategy throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling. 

• Maintain Regulatory Documentation: Develop and maintain regulatory documentation, including Design History File (DHF), Technical Documentation, as well as Device Master Record (DMR) and Device History Records (DHR). 

• Own Regulatory Submissions: Prepare, review, and submit documentation for EU MDR, FDA, and other international markets. 

• Monitor Product Safety: Participate in post-market surveillance, CAPA, and complaint management activities. 

• Interact withRegulatory Bodies: Coordinate communications with regulatory bodies and drive certification projects and vigilance activities, ensuring timely reporting and compliance. 

• Empower Process Owners and Teams: Guide process owners and product teams to integrate regulatory requirements into our Quality Management System and deliver impactful training on compliance and regulatory topics. 

• Stay Ahead: Monitor regulatory trends and provide intelligence to keep Neko Health at the forefront of compliance. 

What You Bring

• Education: BSc or MSc in law, medicine, pharmacy, engineering, or a related field. 

• Experience: 4–5+ years in regulatory affairs or quality management for active medical devices and software as a medical device. 

• Expertise: Deep knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, IEC 60601-1, IEC 62304, ISO 14971, and more. 

• Skills: Analytical, detail-oriented, and able to interpret complex regulations to provide risk-based recommendations. 

• Communication: Excellent interpersonal and writing skills; able to engage and inspire both internal teams and external stakeholders. 

• Mindset: Self-motivated, independent, and ready to take ownership in a dynamic, quality-focused environment. 

• Languages: Fluent English required; Swedish proficiency is a plus. 

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.

Hiring Process

Candidates progress from application and structured screening through thoughtfully designed interviews culminating in a formal offer and final pre-employment checks before joining the team.

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.