Regulatory Software Engineer
Regulatory software Engineer (Medical Device / AI Imaging)
Remote | 6 Month Contract | ASAP Start (M/F/D)
A leading organisation within the medical equipment manufacturing sector is seeking an experienced Regulatory software Engineer to support the development of advanced AI‑enhanced MRI technologies. This role offers the opportunity to contribute to state‑of‑the‑art imaging solutions within a highly regulated and innovation‑driven environment.
Key Responsibilities
- Develop and maintain software components for AI‑integrated MRI systems
- Support the development of image processing tools and algorithms
- Conduct verification and validation (V&V) activities in line with medical device standards
- Produce clear, compliant documentation, including test plans, reports, and technical records
- Collaborate with quality, regulatory, and engineering teams to ensure adherence to MDR and ISO 13485 requirements
- Operate within non‑compliant development environments aligned with medical device lifecycle processes
Essential Experience
- Minimum of 3 years' experience as a Software Engineer within medical devices, imaging, or a similarly regulated field
- Proven experience in:
- Image processing
- Verification and validation
- Documentation and testing
- MDR (Medical Device Regulation)
- ISO 13485 compliance
- Familiarity with medical device software development processes and regulatory expectations
Desirable Skills:
- Experience with C++
- Background in MRI technologies or AI/ML imaging applications
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