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.