Regulatory Specialist – UKCA Class I Software as a Medical Device

Role Overview

• 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.