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- Tasks: Guide innovative AI and software products through regulatory processes and compliance.
- Company: Join a leading consultancy in digital health and MedTech innovation.
- Benefits: Remote work, collaborative culture, and opportunities for professional growth.
- Other info: Be part of a dynamic team driving change in the MedTech landscape.
- Why this job: Shape the future of AI-driven healthcare solutions and make a real impact.
- Qualifications: Experience in software development lifecycle and digital health compliance.
The predicted salary is between 36000 - 60000 £ per year.
Regulatory Affairs Consultant – SaMD & AI Driven Devices
Remote (UK based) | Software, AI, and Digital Health Focus | Permanent
Whether it’s mapping a regulatory strategy for an AI based clinical tool, drafting FDA ready documentation, stress testing a technical file before CE marking, or simple planning a launch, the types of projects you could work on are endless with this consultancy.
You’ll join a well known company that’s supporting some of the most exciting software and AI based MedTech products in the UK and EU. Even though the position is remote, the business cultivate a culture of collaboration, so you will never be alone.
What Your Week Might Look Like
- Coaching a founder through the early regulatory roadmap for their clinical decision support tool
- Reviewing technical documentation and dossiers before it goes to a Notified Body
- Advising on post market surveillance plans for a newly launched app based diagnostic
- Shape strategy for new SaMD technologies
The skillset that will thrive:
- Strong grasp of the software and AI development lifecycle, you understand the moving parts and how they map to compliance requirements.
- Hands-on experience in digital health, ideally with connected devices or wearables.
- Proven ability to take products from development through to submission (UKCA, CE, FDA)
- Solid working knowledge of IEC 62304 (software lifecycle)
As demand for their digital health expertise accelerates, this role will shape how the consultancy evolves in the SaMD and AI space.
You won’t just contribute but actually define the direction.
Regulatory Affairs Consultant employer: Medibeam
Contact Detail:
Medibeam Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Consultant
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory affairs space, especially those working with AI and digital health. Use platforms like LinkedIn to connect and engage with them; you never know who might have a lead on your dream job!
✨Tip Number 2
Show off your expertise! Prepare a portfolio showcasing your experience with SaMD and AI-driven devices. Highlight specific projects where you’ve navigated regulatory pathways or contributed to compliance strategies. This will make you stand out when chatting with potential employers.
✨Tip Number 3
Practice makes perfect! Get ready for interviews by rehearsing common questions related to regulatory affairs and digital health. Think about how you can demonstrate your understanding of the software development lifecycle and compliance requirements during these chats.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of exciting opportunities that match your skills. Plus, applying directly shows your enthusiasm and commitment to joining our team in shaping the future of MedTech.
We think you need these skills to ace Regulatory Affairs Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight your knowledge of software and AI development, as well as any hands-on experience in digital health. We want to see how you can contribute to our exciting projects!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs in the MedTech space. Share specific examples of your past work that align with the role, and let us know how you can help shape our consultancy's future.
Showcase Your Regulatory Knowledge: Since this role involves navigating complex regulations, make sure to demonstrate your understanding of compliance requirements, especially around UKCA, CE, and FDA submissions. We’re looking for someone who can hit the ground running, so don’t hold back on your expertise!
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 us you’re keen to join our collaborative culture right from the start!
How to prepare for a job interview at Medibeam
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulations surrounding SaMD and AI-driven devices. Familiarise yourself with IEC 62304 and the submission processes for UKCA, CE, and FDA. Being able to discuss these confidently will show that you’re not just a candidate, but a knowledgeable asset.
✨Showcase Your Experience
Prepare specific examples from your past work where you've successfully navigated regulatory challenges. Whether it’s drafting documentation or advising on post-market surveillance, having concrete stories ready will help you stand out and demonstrate your hands-on experience.
✨Understand the Company Culture
Since this role is remote but emphasises collaboration, be ready to discuss how you thrive in team settings. Share experiences where you’ve worked effectively with others, even from a distance, to show that you can fit into their culture seamlessly.
✨Ask Insightful Questions
Prepare thoughtful questions about the company’s projects and future direction in the SaMD and AI space. This not only shows your genuine interest but also gives you a chance to assess if the company aligns with your career goals.