Mercurial Dance | EmbodyXR
Freelance Opportunity: Digital Health / MHRA Regulatory Consultant (XR & Software as a Medical Device)
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Job Description
Role Overview
We're looking for someone with practical experience of UK medical device regulation for software, particularly Software as a Medical Device (SaMD), to help us establish an appropriate regulatory strategy as the product evolves.
Scope of Work
- Review the current EmbodyXR product against UK MHRA guidance and relevant IMDRF software classification frameworks.
- Advise on intended purpose, product claims and regulatory positioning.
- Determine whether the product falls within or outside UK Medical Device Regulations at each stage of development.
- Develop a staged regulatory roadmap covering research, commercial launch and future healthcare applications.
- Prepare documentation required for MHRA Class I registration if appropriate, including technical documentation and supporting evidence.
- Advise on Quality Management System requirements, software lifecycle processes, risk management and usability considerations where applicable.
- Provide guidance on future readiness for NHS adoption, DTAC and NICE Evidence Standards should the product progress towards regulated digital health applications.
Company Description
Mercurial Dance is a creative studio that combines dance, virtual reality, and motion capture to design experiences that move and inspire people. The team works at the intersection of performance, technology, and wellbeing, exploring innovative ways to engage bodies and minds through immersive tools. By defying convention and experimenting with emerging XR technologies, the organization aims to ignite imagination and expand what is possible in digital health and embodied interaction. Applicants will join a small, specialist team that values collaboration, curiosity, and rigor in both artistic and technical practice.
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Lead Product
We're working on EmbodyXR® combines immersive XR technology, movement and interactive storytelling to address anxiety management for young adults. The current project is funded through Innovate UK and is being developed with academic research partners. Future product development & release will be evidence-led and aligned with appropriate regulatory frameworks.
Role Description
This is a remote/hybrid, contract role for a Digital Health / MHRA Regulatory Consultant specialising in XR and Software as a Medical Device (SaMD). The consultant will advise on regulatory pathways for digital health products in the UK, particularly those involving immersive technologies, motion capture, and VR-based interventions. Day-to-day tasks include interpreting MHRA and relevant international regulations, assessing product concepts for medical device classification, and mapping requirements for clinical evaluation, risk management, and post-market surveillance. The role involves drafting and reviewing regulatory documentation, contributing to technical files and labeling, and advising on data protection, safety, and quality considerations related to XR and SaMD. The consultant will collaborate closely with creative technologists, clinicians, and project leads to ensure compliance while supporting innovation and timely product development.
Essential Experience
- Demonstrable experience supporting MHRA medical device registrations for digital health software or SaMD.
- Strong understanding UKCA/CE marking processes, and classification of Software as a Medical Device (SaMD) for digital health products.
- Experience preparing Technical Documentation and regulatory submissions.
- Knowledge of digital therapeutics, wellbeing applications or immersive technologies.
- Experience with regulatory strategy and documentation, including technical files, clinical evaluation plans, risk management, and post-market surveillance for medical devices or health software.
- Knowledge of XR, VR, motion capture, or immersive technology applications in healthcare, rehabilitation, or wellbeing, and familiarity with associated safety and usability considerations.
- Understanding of health data protection, cybersecurity, and ethical considerations in digital health, including UK GDPR and relevant standards or guidance.
- Proven ability to work collaboratively with multidisciplinary teams (e.g., clinicians, designers, engineers, and artists) and communicate complex regulatory requirements in clear, practical terms.
- Experience as a regulatory consultant or in a regulatory affairs role within medical devices, digital therapeutics, or health technology is strongly beneficial.
- Relevant academic background in a scientific, clinical, regulatory, or technical field (e.g., regulatory affairs, biomedical engineering, health informatics, or a related discipline).
- Comfort working remotely, managing own schedule, and delivering clear outputs and recommendations within agreed timelines for contract-based projects.
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The role can be delivered remotely, but in person team meetings may be needed in our offices in Coventry.
Application Process
If successful the role will be offered only to UK based freelancers with right to work in the UK and offered on a self-employed basis. Due to funding restrictions the work needs to take place in the UK.
How to Apply Following completing the screening questions you will be invited to send your CV and a covering email words describing your experience and how you will approach delivering this role.
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