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- Tasks: Drive regulatory excellence for innovative AI/ML medical devices and ensure compliance with global standards.
- Company: Join Neko Health, a pioneer in preventative healthcare technology.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Dynamic, collaborative environment with a focus on quality and innovation.
- Why this job: Shape the future of healthcare while making a real difference in people's lives.
- Qualifications: 4-5+ years in software development with AI/ML experience; regulatory affairs knowledge is a plus.
The predicted salary is between 60000 - 80000 £ per year.
MissionNeko 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 Engineer who’s passionate about tackling complex regulatory strategies, enjoys working with cutting-edge medical devices, and thrives in a fast-paced, collaborative and distributed environment. We are looking for you that have extensive experience from software development, artificial intelligence, and machine learning in the medical device space.
What You’ll Do
- Drive Regulatory Excellence: Ensure our cutting-edge software meets global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market.
- Implement Regulatory Requirements for AI and ML: Coordinate activities and efforts across AI and ML algorithms and device software implementation and ensure regulatory requirements are implemented in our processes.
- Support Software Development: Advise on regulatory strategy throughout the software lifecycle, influencing architecture and design, risk management, supplier selection, and labeling.
- Prepare Software Documentation: Participate in activities to prepare necessary software documentation for our software modules, components, algorithms, and devices as needed.
- 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 software development with artificial intelligence and machine learning algorithms. Experience from regulatory affairs or quality management for software as a medical device is a plus.
- Expertise: Deep knowledge of EU AI Act, FDA AI Guidance, IEC 62304, IEC 82304-1, IEC 81001-5-1. Knowledge of EU MDR, FDA CFR (Title 21 Subchapter H), UK MDR, ISO 13485, ISO 14971, and more is a plus.
- 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.
Regulatory Affairs Engineering Lead (AI/ML) in London employer: Neko Health
Contact Detail:
Neko Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Engineering Lead (AI/ML) in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its mission. Understand how your skills in regulatory affairs and AI/ML can contribute to their goals. Tailor your responses to show how you can help them redefine preventative care.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. Focus on articulating your experience with software development and regulatory strategies clearly.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of the Neko Health team and its mission.
We think you need these skills to ace Regulatory Affairs Engineering Lead (AI/ML) in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Affairs Engineering Lead role. Highlight your experience with AI/ML in medical devices and how it aligns with Neko Health's mission of preventative care.
Showcase Your Skills: Don’t just list your qualifications; demonstrate how your analytical and communication skills have made a difference in past projects. We want to see how you can drive regulatory excellence and support software development.
Be Clear and Concise: When writing your application, keep it straightforward and to the point. Use clear language to explain your experience with regulations like the EU AI Act and FDA guidance, as this will show us you understand the complexities of the role.
Apply Through Our Website: We encourage you to submit your application through our website. This way, you’ll ensure it reaches the right people directly and you can easily track your application status!
How to prepare for a job interview at Neko Health
✨Know Your Regulations
Familiarise yourself with the key regulations mentioned in the job description, like the EU AI Act and FDA AI Guidance. Being able to discuss these in detail will show your expertise and readiness for the role.
✨Showcase Your Experience
Prepare specific examples from your past work that highlight your experience in software development, AI, and ML within the medical device space. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Communicate Clearly
Practice explaining complex regulatory concepts in simple terms. This will demonstrate your excellent communication skills and ability to engage with both technical teams and non-technical stakeholders.
✨Stay Ahead of Trends
Research current trends in regulatory affairs related to AI and ML. Be ready to discuss how you can help Neko Health stay at the forefront of compliance and what proactive steps you would take in this fast-paced environment.