Regulatory specialist - UKCA Class I Software as a Medical Device (Contract)

Regulatory specialist - UKCA Class I Software as a Medical Device (Contract)

Contract Length: 3 months | 20 hours per week 

Pay rate: £75 per hour  | Outside IR35

Location: Remote, anywhere within the UK 

Start Date: ASAP

The role

We’re looking for an experienced Regulatory Specialist to join Isla Health on a fixed-term contract to lead and deliver our UKCA Class I Software as a Medical Device (SaMD) self-certification and MHRA registration.

This is a hands-on role focused on bringing our regulatory workstream to submission readiness. You will work closely with our Engineering, Product, Clinical Safety and Operations teams to ensure all required documentation is complete, coherent and proportionate to a Class I device.

Importantly, this role is not starting from a blank slate. Isla Health is ISO 9001 certified and already operates in alignment with many of the relevant controls and principles across applicable medical device standards. A strong Quality Management System foundation is in place. The focus of this role will be on refining, consolidating and formalising existing documentation and controls, ensuring they are aligned, defensible and ready for UKCA self-certification and MHRA submission.

The successful candidate will take ownership of the regulatory workstream, preparing and finalising the Technical File and supporting documentation required for UKCA self-certification, and leading the MHRA manufacturer and device registration submission.

We’re looking for someone who is comfortable working independently, embedding within a fast-moving team, and translating technical and clinical inputs into clear, structured and defensible regulatory documentation.

Who We Are

Isla Health is a venture-backed healthtech startup, supporting our partners across the UK, EU and internationally beyond this. We have built a new category of healthcare technology which we refer to as the Digital Pathway Platform (DPP). Founded in 2019, we now support 25% of NHS Trusts and a submission of patient data is made on the platform every 20 seconds.

As a company we are all laser focused on enabling a scalable model of care which empowers healthcare staff and improves patient outcomes. The DPP supports this by setting up digital pathways which are remote-first and asynchronous. As pathways harness sophisticated automation, clinical algorithms and intelligent cohorting, patients always take the optimised route through their pathway, thereby delivering a step change in clinical productivity.

Over the 3 months you will:

• Lead submission readiness: Provide leadership and structure to complete UKCA Class I self-certification documentation and ensure the organisation reaches a state of confident regulatory submission readiness. 
• Own and finalise the Technical File: Consolidate and structure all regulatory documentation into a complete Technical File aligned with Annex I and Annex X of the UK Medical Devices Regulations 2002. 
• Lead Risk Management (ISO 14971): Facilitate hazard identification discussions, complete the Risk Management File, define risk acceptability criteria and produce the final Risk Management Report for approval.
• Strengthen software lifecycle compliance (IEC 62304): Confirm software safety classification and ensure traceability between requirements, risks and verification artefacts. Close documentation gaps proportionate to a Class I device.
• Develop key regulatory artefacts: Finalise the Clinical Evaluation Report (literature-based), complete the General Safety and Performance Requirements (GSPR) matrix, align intended use and marketing claims, and prepare the Declaration of Conformity.
• Establish post-market processes: Document Post-Market Surveillance planning and vigilance procedures aligned with UK regulatory requirements. 
• Prepare and coordinate submission: Prepare the final regulatory documentation set and coordinate MHRA manufacturer and device registration submission.
• Work cross-functionally: Collaborate closely with Engineering, Product, Clinical Safety and Operations teams to translate technical implementation into regulatory documentation.

Requirements

• Medical device regulatory experience: Experience working in medical device regulatory affairs with direct involvement in preparing regulatory documentation.
• Technical File experience: Experience preparing or owning Technical Documentation / Technical Files for medical devices.
• Software as a Medical Device experience: Experience working on regulatory documentation for Software as a Medical Device.
• UK regulatory knowledge:
• Practical experience applying the UK Medical Devices Regulations 2002, particularly for Class I devices.
• Risk and software lifecycle expertise
• Experience applying:
• ISO 14971 – Risk Management for Medical Devices
• IEC 62304 – Medical Device Software Lifecycle Processes
• Regulatory documentation drafting:
• Experience preparing regulatory artefacts such as:
• Clinical Evaluation Reports
• General Safety and Performance Requirements matrices
• Declarations of Conformity
• Technical collaboration: Comfortable working directly with software engineering teams and interpreting technical artefacts.

Diversity and Inclusion

Isla is an equal opportunity employer and is committed to building an inclusive and diverse team. We encourage all qualified candidates to apply. Isla does not discriminate against anyone on the basis of their race, gender, disability, religion, national origin, age, or any other protected category. We choose to celebrate our team’s differences and see them as one of our most valuable assets.

Recruitment is not one-size-fits-all and we're happy to tailor our hiring process to better meet the needs of individual applicants. Please email [email protected] with any requests for support.