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- Tasks: Shape regulatory tools and support AI development to enhance compliance in MedTech.
- Company: Innovative London startup transforming MedTech compliance with a collaborative culture.
- Benefits: Competitive salary, equity options, 25 days off, and flexible work arrangements.
- Why this job: Be the first regulatory hire and make a real impact on MedTech compliance.
- Qualifications: 5-7 years in MedTech regulatory, strong communication skills, and AI-savvy.
- Other info: Work alongside experienced advisors and enjoy excellent career growth opportunities.
The predicted salary is between 36000 - 60000 £ per year.
Join us as our first regulatory hire. Build the tools you wish existed, help every RA team stuck in the same pain. You’ve spent years navigating regulatory complexities. You know where the pains are. Now imagine building the tools you wish existed, an AI that actually understands what auditors look for, what submissions need, what "compliant" really means.
This is rare: a chance to shape a product from the inside, with founders who’ve lived the problem and investors who get the space.
About Us
Compliance in MedTech is complex, manual, and error-prone, but if done correctly can be a differentiator, a moat, and a strategic endeavour. We’re a startup in London transforming how MedTech companies do compliance helping teams can move faster with confidence. Backed by Meridian Health Ventures, Antler, Vento Ventures, and angels who are regulatory experts and MedTech executives (many of whom use our product).
Francesco (CEO & co-founder) spent a decade in MedTech bringing multiple lifesaving products from concept to patients, he’s lived the compliance pain we’re solving. Mihai (CTO & co-founder) has a PhD on decision making in multi-agent systems and led research in safe and interactive planning for self-driving.
The Role
You’ll be the regulatory expert working alongside our AI engineers. Your job: teach them what "great" looks like.
Day-to-day, you will:
- Help AI development: extract requirements from regulations, validate AI outputs, build datasets that teach the system to think like a regulatory professional.
- Shape the product: research client and industry pain points, review regulatory updates, identify opportunities for improvement.
- Create content: write blog posts, guides for clients to decode new regulations and establish Klaris’s voice in the market.
- Work with clients: support regulatory teams, understand their real-world workflows, and translate insights into product improvements.
- Maintain internal compliance: help Klaris achieve and maintain certifications (IEC 62304, ISO 27001).
You’ll work closely with our regulatory advisors with a combined 70 years of experience in the field. They will provide strategic guidance and specific knowledge; you’ll drive daily execution.
What We’re Looking For
5-7 years in MedTech regulatory and/or quality. You’ve authored submissions, built QMS documentation, or led compliance initiatives. You have a track record of establishing or adapting regulatory processes to achieve better outcomes, reduced timelines, improved quality, and successful certifications. You think about how tech can enhance and change existing regulatory workflows, not just digitise the status quo.
Think in principles, not just procedures. You should be able to read a regulation and explain what it actually requires, not just quote it.
High agency, AI-native. You don’t need startup experience, but comfort with incomplete information, and genuine excitement about building something new. You use AI as a multiplier: parsing standards, building datasets, cross-referencing faster than any team could manually.
Core Skills
- Regulatory submissions: You’ve authored (not just contributed to) an EU MDR dossier, FDA 510(k)s, or similar.
- In-depth regulatory or quality: You’ve owned one or multiple pieces of the compliance machine (e.g., clinical evaluation, post-market surveillance, or change management).
- Hands-on QMS experience: You have implemented and maintained an ISO 13485 quality system.
- Clear communication: You can explain complex requirements to engineers and product people without drowning them in jargon.
What we offer
Competitive compensation: base salary + real equity, with flexibility to adjust the cash/equity mix for more senior candidates. Enough time off: 25 days + UK.
Regulatory & Quality Specialist in London employer: Klaris
Contact Detail:
Klaris Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory & Quality Specialist in London
✨Tip Number 1
Network like a pro! Reach out to people in the MedTech space, especially those who’ve been through the regulatory maze. Attend industry events or webinars and don’t be shy about introducing yourself – you never know who might have a lead on your dream job!
✨Tip Number 2
Show off your expertise! Create a portfolio that highlights your past regulatory submissions and compliance initiatives. This is your chance to demonstrate how you’ve tackled challenges and improved processes – make it shine!
✨Tip Number 3
Get involved in discussions online! Join forums or LinkedIn groups focused on MedTech and regulatory affairs. Share your insights and ask questions; this not only builds your knowledge but also puts you on the radar of potential employers.
✨Tip Number 4
Apply directly through our website! We’re looking for someone who can help us shape our product, so don’t hesitate to showcase how your unique skills can contribute to our mission. Let’s build something amazing together!
We think you need these skills to ace Regulatory & Quality Specialist in London
Some tips for your application 🫡
Show Your Passion for Regulatory Work: When you write your application, let your enthusiasm for regulatory and quality work shine through. We want to see how your experience aligns with our mission to transform MedTech compliance. Share specific examples of how you've tackled regulatory challenges in the past!
Tailor Your Application: Make sure to customise your CV and cover letter for this role. Highlight your relevant experience in MedTech and any specific projects that demonstrate your ability to navigate regulatory complexities. We love seeing how you can connect your background to what we’re building at Klaris.
Be Clear and Concise: We appreciate straightforward communication, so keep your application clear and to the point. Avoid jargon where possible and focus on conveying your skills and experiences in a way that’s easy to understand. Remember, we want to know what you can bring to the table!
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team at Klaris!
How to prepare for a job interview at Klaris
✨Know Your Regulations Inside Out
Make sure you brush up on the latest MedTech regulations and compliance standards. Be ready to discuss how you've navigated these complexities in your previous roles, and think about how you can apply that knowledge to help shape the product at Klaris.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've identified pain points in regulatory processes and implemented solutions. This role is all about building tools to alleviate those pains, so demonstrating your ability to think critically and innovatively will set you apart.
✨Communicate Clearly and Effectively
Practice explaining complex regulatory concepts in simple terms. You'll need to work closely with engineers and product teams, so being able to bridge the gap between technical jargon and clear communication is key.
✨Demonstrate Your AI Savvy
Since this role involves working alongside AI engineers, be prepared to discuss how you envision AI enhancing regulatory workflows. Share any experiences you have with tech in compliance and how you see it transforming the industry.
