Job Title

Senior Systems & Regulatory Software EngineerMedical Devices | High Salary or High-Rate Contract | Kent | HybridA cutting-edge medical technology company based in Kent is seeking an experienced Systems / Regulatory Software Engineer to play a pivotal role in the development of next-generation medical devices.This is a rare opportunity to join a business where engineering rigour, regulatory excellence, and modern software practices genuinely coexist. The role can be structured either as a highly competitive permanent position or a well-remunerated contract engagement, depending on preference.The OpportunityYou will work at the heart of a multidisciplinary engineering team, helping to define, govern, and deliver high-assurance medical software across the full product lifecycle.This role suits someone who enjoys systems thinking, understands how to balance regulatory compliance with delivery pace, and can act as a technical authority across IEC 62304, ISO 13485, and risk-driven development.You’ll be influential in shaping process, architecture, and engineering culture, while remaining close to the technical detail.Key ResponsibilitiesOwn and evolve software lifecycle processes aligned to IEC 62304 and ISO 13485Lead system-level requirements, architecture, and risk management activitiesEnsure compliance with ISO 14971 (beneficial standard) risk management and medical device regulationsAct as a technical interface between software, systems, QA/RA, and hardware teamsSupport audits, technical files, and regulatory submissionsGuide and mentor engineers on high-assurance development practicesDrive continuous improvement across SDLC, DevOps, and validation activitiesTechnical EnvironmentLanguages: C / C++Platforms: Embedded Linux, YoctoTooling: Azure DevOps (CI/CD, requirements, test management)Operating Context: Safety-critical, regulated medical softwareBackground & ExperienceStrong experience in medical device software or similarly regulated environmentsProven application of IEC 62304 and ISO 13485 in real-world product developmentSolid understanding of systems engineering, requirements, and traceabilityComfortable working across embedded software, DevOps, and quality processesAble to influence both technical delivery and regulatory strategyConfident communicator with engineers, quality, and senior stakeholdersWhy This Role?High-impact position within a genuinely innovative medical technology companyChoice of high-salary permanent role or premium contract engagementWork on life-critical products with real-world clinical impactHybrid working with a Kent-based engineering hubEngineering-led culture that values experience, pragmatism, and qualityIf you are a systems-minded engineer with deep regulatory expertise and want to work at the forefront of medical technology—without bureaucracy for bureaucracy’s sake—we’d welcome a confidential conversation.