Regulatory Lead

Healthtech-1
United Kingdom
Workplace: OnsiteFull timeFunction: Quality & Regulatory (Non-Software)Skills: ["Communication","Change management","Detail-oriented","Commercial fluency","Numerical fluency"]

Own the Class IIa medical device regulatory strategy and technical file for AI care navigation and appointment booking in the NHS App. Lead gap analysis and implementation toward IIa requirements, including MHRA technical file work, post-market surveillance, and ongoing governance. Drive evidence generation for NHS integration and help shape safety requirements across PRDs, design reviews, and release gates, working closely with a small clinical team and product/engineering.

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FursaFursa
Healthtech-1
Healthtech-1
3 days ago

Regulatory Lead

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Source: Company careers pageValidated by: Fursa AI
Last checked: 1 hour agoStatus: Live

Job Summary

Own the Class IIa medical device regulatory strategy and technical file for AI care navigation and appointment booking in the NHS App. Lead gap analysis and implementation toward IIa requirements, including MHRA technical file work, post-market surveillance, and ongoing governance. Drive evidence generation for NHS integration and help shape safety requirements across PRDs, design reviews, and release gates, working closely with a small clinical team and product/engineering.
Location: United Kingdom
Workplace: Onsite
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Mid level

Key Responsibilities

  • •Own the Class IIa medical device strategy and technical file, including completing and planning Class IIa steps.
  • •Lead post-market surveillance and ongoing governance, including reporting cadence.
  • •Generate evidence for NHS App integration and author academic papers, white papers, and clinical explainers for ICBs.
  • •Support clinical safety work by producing and executing a Class IIa gap analysis and driving implementation milestones with timelines.
  • •Co-own safety requirements with product and engineering across PRDs, design reviews, and release gates, including data for safety monitoring and risk detection.

Pay and Benefits

Perks:Learning BudgetPensionParental LeaveRemote Work

Key Requirements

  • •Led an MDR or CE certification process before for a class 2 or class 3 device, in consultancy and/or in-house.
  • •Work independently to understand and apply a clinical safety system, processes, products, and risks.
  • •Create and deliver a gap analysis against Class IIa requirements and drive a compliant implementation plan.
  • •Lead preparation and execution of MHRA Class IIa technical file work and post-market surveillance processes.
  • •Author and contribute evidence that demonstrates positive health outcomes for NHS integration.
Experience:Medical devicesHealthcareNHS
Skills:CommunicationChange managementDetail-orientedCommercial fluencyNumerical fluency
Certifications:ISO13485
Tech Stack:Class IIaMDRCEUKCAMHRAISO13485Post-market surveillanceTechnical fileUKCA +/ CEMedical device strategyEvidence generation

Company Brief

Healthtech-1
Builds automation tools for primary care to remove administrative work for NHS staff, including automated patient registrations and appointment booking to improve access and efficiency across GP practices.
Industry: HealthTech
Company Size: Small (11 to 50 employees)
Growth: Early Stage Startup
Funding: Seed
Headquarters: London, United Kingdom
Founded: 2021
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