At a Glance
- Tasks: Drive regulatory excellence and ensure compliance for cutting-edge medical software.
- 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 innovation and quality.
- Why this job: Shape the future of medical tech and make 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.
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 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. 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) employer: Neko Health
At Neko Health, we are not just redefining healthcare; we are creating a culture of innovation and collaboration that empowers our employees to make a real difference in people's lives. With a focus on professional growth, we offer extensive training and development opportunities in a fast-paced environment where your contributions directly impact the future of medical technology. Join us in our mission to make preventative care accessible to all, and enjoy the unique advantage of working with cutting-edge AI and ML technologies in a supportive and inclusive workplace.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Engineering Lead (AI/ML)
✨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 Neko Health and understanding their mission. Be ready to discuss how your experience in regulatory affairs and AI/ML aligns with their goals. Show them you're not just another candidate, but someone who genuinely cares about making a difference.
✨Tip Number 3
Practice your pitch! You want to be able to clearly articulate your skills and experiences that make you the perfect fit for the Senior Regulatory Affairs Engineer role. Keep it concise and impactful—think of it as your personal brand statement.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the Neko Health team and contributing to their mission.
We think you need these skills to ace Regulatory Affairs Engineering Lead (AI/ML)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the role of Senior Regulatory Affairs Engineer. Highlight your experience with AI, ML, and regulatory affairs in the medical device space. We want to see how your skills align with our mission at Neko Health!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Share your passion for preventative care and how you can contribute to our mission. Be sure to mention specific experiences that demonstrate your expertise in regulatory strategies and software development.
Showcase Your Communication Skills:Since excellent communication is key for this role, make sure your application reflects your writing skills. Use clear, concise language and structure your documents well. We love seeing candidates who can engage and inspire through their words!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at Neko Health!
How to prepare for a job interview at Neko Health
✨Know Your Regulations
Familiarise yourself with the key regulations and standards 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 effectively.
✨Engage with the Team
Demonstrate your collaborative spirit by discussing how you've worked with cross-functional teams in the past. Neko Health values teamwork, so showing that you can empower process owners and integrate regulatory requirements will be a big plus.
✨Stay Ahead of Trends
Research current trends in regulatory affairs related to AI and ML. Be prepared to share insights on how these trends could impact Neko Health's strategies. This shows your proactive mindset and commitment to keeping the company at the forefront of compliance.
