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.