At a Glance
- Tasks: Lead strategy for medical device certification and collaborate with cross-functional teams.
- Company: Accurx is a fast-growing healthcare tech company improving communication between patients and healthcare teams.
- Benefits: Enjoy a dynamic work environment, opportunities for growth, and the chance to make a real impact.
- Why this job: Join us to shape the future of healthcare and improve lives through innovative technology.
- Qualifications: Experience with UK MDR, digital health products, and strong communication skills are essential.
- Other info: This is a six-month fixed-term contract with a focus on making healthcare better.
The predicted salary is between 43200 - 72000 ÂŁ per year.
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 …
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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
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Work cross-functionally with Product, Clinical, Privacy, and Technical teams to embed medical device processes and thinking into how we design and build
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Support the creation and implementation of our Quality Management System (QMS) and related processes, ensuring we’re audit-ready
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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…
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You’ve successfully taken a digital health or SaMD product through certification under UK MDR
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You’re highly self-starting, proactive, and comfortable working autonomously
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You have deep knowledge of UK MDR and strong working familiarity with IEC 62304, ISO 14971, and ISO 13485
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You’ve worked in fast-moving digital health teams and can balance regulatory compliance with the realities of iterative product development
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You’re a strong communicator who can translate regulatory requirements into practical actions for non-regulatory colleagues.
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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 .
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Medical Devices & Regulatory Consultant employer: Accurx Limited.
Contact Detail:
Accurx Limited. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Medical Devices & Regulatory Consultant
✨Tip Number 1
Familiarise yourself with the latest UK MDR regulations and guidelines. Being well-versed in these will not only help you during interviews but also demonstrate your commitment to staying updated in a fast-evolving field.
✨Tip Number 2
Network with professionals in the medical devices and regulatory field. Attend relevant webinars or industry events to connect with others who can provide insights or even referrals for the role at Accurx.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully navigated regulatory challenges in past roles. This will showcase your hands-on experience and problem-solving skills, which are crucial for this position.
✨Tip Number 4
Research Accurx's products and their impact on healthcare communication. Understanding their mission and how your role as a Medical Devices & Regulatory Consultant fits into their goals will help you articulate your passion for the position.
We think you need these skills to ace Medical Devices & Regulatory Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience with class I-III medical devices and software as a medical device (SaMD). Emphasise any relevant projects where you've successfully navigated UK MDR requirements.
Craft a Compelling Cover Letter: In your cover letter, express your passion for improving healthcare and how your skills align with Accurx's mission. Mention specific experiences that demonstrate your ability to work cross-functionally and your knowledge of UK MDR.
Showcase Regulatory Expertise: Clearly outline your familiarity with IEC 62304, ISO 14971, and ISO 13485 in your application. Provide examples of how you've applied this knowledge in previous roles, particularly in fast-paced digital health environments.
Demonstrate Communication Skills: Highlight instances where you've effectively communicated complex regulatory requirements to non-regulatory colleagues. This will show your ability to bridge the gap between technical and non-technical teams, which is crucial for this role.
How to prepare for a job interview at Accurx Limited.
✨Know Your Regulations
Familiarise yourself with UK MDR and relevant standards like IEC 62304, ISO 14971, and ISO 13485. Be prepared to discuss how your experience aligns with these regulations and how you've successfully navigated them in past roles.
✨Showcase Cross-Functional Collaboration
Highlight your experience working with diverse teams such as Product, Clinical, and Technical. Prepare examples of how you’ve embedded regulatory processes into product development and how you communicate complex regulatory requirements to non-regulatory colleagues.
✨Demonstrate Proactivity
Accurx values self-starters who can work autonomously. Share instances where you took the initiative to solve problems or improve processes, especially in fast-paced environments like digital health.
✨Express Your Passion for Healthcare
Convey your genuine interest in making a difference in healthcare. Discuss specific examples of how your work has positively impacted patient outcomes or improved healthcare communication, aligning with Accurx's mission.