Regulatory Consultant – SaMD & AI Focus
Fully Remote | £60,000 – £80,000 per annum
Imagine starting your day from the comfort of your home office, fully remote yet fully connected. You log into a virtual meeting with a dynamic startup, eager to bring their innovative SaMD product to market.
As a Regulatory Consultant, your expertise is instrumental in helping them navigate the complex landscape of global submissions, ensuring compliance with MDR, IVDR and FDA requirements.
Later, you’re reviewing technical documentation for an SME preparing their AI-powered diagnostic tool for a critical 510(k) submission. Your engineering background enables you to guide their team through early-stage design considerations, ensuring their product is not only compliant but also robust and market-ready.
Your afternoon might involve advising another client on post-market surveillance strategies, leveraging your knowledge of clinical evaluation and vigilance to ensure they maintain access to international markets.
You’ll collaborate with a small yet highly skilled team of professionals who are as passionate about MedTech innovation as you are. Together, you’re shaping the future of healthcare by supporting companies at the forefront of digital health.
The variety of projects keeps every day fresh and challenging.
From startups seeking funding to SMEs expanding their portfolios, you’re constantly exposed to new ideas and technologies.
The company’s culture of collaboration means you’re never working in isolation, with a team of 11 experts who value knowledge-sharing and client success.
This role also offers the chance to grow.
The consultancy’s proven track record of training and promoting from within means your career can evolve alongside the business.
Whether it’s taking on more responsibility or specialising further in SaMD and AI, the opportunities are there for you to seize.
And while you’re contributing to groundbreaking projects, you’ll enjoy the flexibility of a fully remote role, earning £60,000–£80,000 for your expertise.
It’s a role that combines professional growth with personal balance, putting you at the heart of MedTech innovation.
About the Role
This is an opportunity to deliver regulatory expertise for a diverse client base, including early-stage startups and SMEs. You’ll guide clients through complex regulatory pathways and be exposed to a variety of responsibilities, typical projects could include;
* Preparing technical documentation and design dossiers.
* Leading regulatory submissions, including EUMDR and EU IVDR, US FDA 510(k)s, PMAs, IDEs, and global market approvals.
* Solving regulatory challenges on classification, technical files, DMRs, DHRs, DHFs, and validation processes.
* Advising or conducting design and product risk management activities.
* Preparing, reviewing, or updating Clinical Evaluation Reports (CERs).
* Supporting post-market surveillance and maintaining market access in the EU, USA, and beyond.
* Ensuring compliance with MDR and other global regulatory requirements.
About You
The ideal candidate will bring:
* A strong foundation in regulatory affairs with SaMD/AI expertise.
* Proven experience navigating MDR and FDA regulatory pathways.
* A background in engineering or the ability to support early-stage product development.
* Exceptional communication skills with a personable, client-facing approach.
* A solutions-oriented, commercially minded mindset to identify opportunities and add value.
About the Company
Founded in 2012, this consultancy is led by Leeanne Baker, a regulatory and quality expert turned CEO who remains hands-on and passionate about MedTech innovation. The company has grown steadily, earning a strong reputation with a loyal client base and repeat business.
What’s in It for You
* Diverse and Exciting Projects: Work with innovative startups and growing SMEs on cutting-edge SaMD and AI medical device developments.
* Fully Remote Role: Flexibility to work from anywhere in the UK or Ireland.
* Career Growth: Join an established consultancy with a proven track record of training and promoting from within.
* Competitive Salary: Earn £60,000–£80,000 while developing your expertise in a rapidly expanding field.
* Be at the Forefront of Innovation: Collaborate on groundbreaking projects shaping the future of digital health and MedTech.
* Collaborative Team Environment: Join a supportive team of 11 professionals in a company known for delivering excellence and fostering long-term client relationships.
If you’re looking for variety, flexibility, and the chance to expand your technical expertise while driving the success of digital health innovations, this role could be your next career move.