Medical Devices & Regulatory Consultant
AccuRx
How you’ll be contributing to Accurx as a Medical Devices & Regulatory Consultant ...
With ambitious plans for the future and exciting product development on the horizon, we’re committed to building with the same care, rigour, and impact that define the rest of our work. That’s where you come in.
We’re looking for an experienced Medical Devices & Regulatory Consultant with experience of class I-III medical devices and software as a medical device (SaMD) to help us navigate and implement the requirements of UK MDR, laying the right foundations for medical device status. This is a high-impact, cross-functional role at the intersection of product, clinical safety, legal, and compliance.
This role is for a six month fixed term contract.
Your day to day tasks, should you choose to accept this mission 🤝...
Lead and build our strategy for medical device certification under UK MDR, with a particular focus on our classification, risk assessment, and clinical evaluation planning
Work cross-functionally with Product, Clinical, Privacy, and Technical teams to embed medical device processes and thinking into how we design and build
Support the creation and implementation of our Quality Management System (QMS) and related processes, ensuring we’re audit-ready
Provide hands-on regulatory expertise for our early SaMD features, laying the foundations for pre-market and post-market surveillance requirements
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Help define and implement our documentation and evidence strategy, including technical files and design dossiers.
Act as our internal expert on UK MDR (and EU MDR if relevant), keeping us aligned and up-to-date as regulations evolve.
We’d like to hear from you if…
You’ve successfully taken a digital health or SaMD product through certification under UK MDR
You’re highly self-starting, proactive, and comfortable working autonomously
You have deep knowledge of UK MDR and strong working familiarity with IEC 62304, ISO 14971, and ISO 13485
You’ve worked in fast-moving digital health teams and can balance regulatory compliance with the realities of iterative product development
You’re a strong communicator who can translate regulatory requirements into practical actions for non-regulatory colleagues.
You care deeply about making a difference in healthcare—and want to work on something that genuinely improves lives.
How you work…
At Accurx we believe in making every day count as we hold a vital role in supporting our users by driving innovative solutions to fix healthcare communication. We want everyone at Accurx to reflect our principles in how they work by looking to:
⭐ Fix healthcare communication
⬆️ Raise the bar
🚙 Be a driver, not a passenger
🤲 Succeed together
💨 Move with urgency
♻️ Be relentlessly resourceful
☝️ Embrace challenge
Check them out for more detail here!
Like the sound of this role and want to know more about the company? Here's more about us...
We’re a fast-growing healthcare technology company which makes it easier for patients and healthcare teams to communicate.
Accurx is where conversations happen with and about patients. Our software helps doctors, nurses, pharmacists, administrators and other professionals to seamlessly connect with both patients and each other.
Our mission is simple: everything we do is to make patients healthier and healthcare staff happier. Today, Accurx is used in 98% of GP practices nationwide and every day more healthcare professionals are using our software in hospitals, pharmacies, care homes and the community.
We’re passionate about staying close to our users, which is why everyone at Accurx visits a GP practice at least twice a quarter to understand how a practice runs, the difficulties they face with technologies and how we can help.
Head over to our main careers page to find out more about the team and our candidate hub.
You can also find out more about us on Medium, LinkedIn and Twitter & Instagram.
Our YouTube channel is full of demos of our product, webinars we have held with our users and some clips about life at Accurx.
Diversity & Inclusion
Accurx is committed to being an inclusive employer. As part of this, we’re glad to accommodate candidates who need adjustments throughout the interview process.
Pre-employment Screening
All successful candidates are asked to complete a Basic DBS check along with other pre-employment checks (referencing & right to work). You can find more on our process here. If you’d like to ask questions before you apply please email jobs@accurx.com.