Principal Systems & Regulatory Software Engineer (Medical Devices)

Senior Systems & Regulatory Software Engineer Medical Devices | High Salary or High-Rate Contract | Kent | Hybrid A 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 Opportunity You 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 Responsibilities Own and evolve software lifecycle processes aligned to IEC 62304 and ISO 13485 Lead system-level requirements, architecture, and risk management activities Ensure compliance with ISO 14971 (beneficial standard) risk management and medical device regulations Act as a technical interface between software, systems, QA/RA, and hardware teams Support audits, technical files, and regulatory submissions Guide and mentor engineers on high-assurance development practices Drive continuous improvement across SDLC, DevOps, and validation activities Technical Environment Languages: C / C++ Platforms: Embedded Linux, Yocto Tooling: Azure DevOps (CI/CD, requirements, test management) Operating Context: Safety-critical, regulated medical software Background & Experience Strong experience in medical device software or similarly regulated environments Proven application of IEC 62304 and ISO 13485 in real-world product development Solid understanding of systems engineering , requirements, and traceability Comfortable working across embedded software, DevOps, and quality processes Able to influence both technical delivery and regulatory strategy Confident communicator with engineers, quality, and senior stakeholders Why This Role? High-impact position within a genuinely innovative medical technology company Choice of high-salary permanent role or premium contract engagement Work on life-critical products with real-world clinical impact Hybrid working with a Kent-based engineering hub Engineering-led culture that values experience, pragmatism, and quality If 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. #J-18808-Ljbffr