At a Glance
- Tasks: Drive regulatory excellence for innovative AI/ML medical devices and ensure compliance with global standards.
- Company: Join Neko Health, a pioneering company redefining preventative healthcare.
- 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 technology and make a real difference in people's lives.
- Qualifications: 4-5+ years in software development with AI/ML; regulatory affairs experience is a plus.
The predicted salary is between 70000 - 90000 £ 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.
- 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.
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: Meeveem Limited
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. As a Regulatory Affairs Engineering Lead, you will be part of a dynamic team dedicated to pioneering preventative care through cutting-edge technology, with ample opportunities for professional growth and development in a supportive environment. Join us in our mission to make health accessible and impactful, where your contributions will directly influence the future of medical technology.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Engineering Lead (AI/ML)
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Meeveem Limited looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Engineering Lead (AI/ML)
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Meeveem Limited. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Meeveem Limited
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Meeveem Limited’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
