Medical Devices & Regulatory Consultant
Medical Devices & Regulatory Consultant
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Job Description
How youll be contributing to Accurx as a Medical Devices & Regulatory Consultant ...
With ambitious plans for the future and exciting product development on the horizon were committed to building with the same care rigour and impact that define the rest of our work. Thats where you come in.
Were 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 were audit-ready
Provide hands-on regulatory expertise for our early SaMD features laying the foundations for pre-market and post-market surveillance requirements
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.
Wed like to hear from you if
Youve successfully taken a digital health or SaMD product through certification under UK MDR
Youre 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
Youve worked in fast-moving digital health teams and can balance regulatory compliance with the realities of iterative product development
Youre a strong communicator who can translate regulatory requirements into practical actions for non-regulatory colleagues.
You care deeply about making a difference in healthcareand 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 Heres more about us...
Were 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.
Were 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.
Diversity & Inclusion
Accurx is committed to being an inclusive part of this were 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 youd like to ask questions before you apply please email .
Required Experience:
Contract
Employment Type
Contract
