Software Safety Engineer

The Scarlet Company Group; Greater London; On-site; GBP 70,000 - 110,000; Full time

Job summary

The Scarlet Company Group is seeking a Software Regulatory Specialist to join Scarlet’s Devices function. You will assess software lifecycle processes for cutting-edge medical devices and translate complex regulatory topics into clear content for customers and prospects.

You will collaborate with Product, Engineering and ML teams, apply the latest standards (IEC 62304) and provide regulatory insights to Sales and Customer Experience.

Qualifications

• You have a degree in computer science or related discipline.
• 4+ years in medical device manufacturing, auditing or research, including 2+ years of safety-critical software development.
• Experience with SDLC, verification & validation testing, software configuration management and cybersecurity.
• You enjoy深入 understanding how things work and challenging the status quo.
• Exceptional written and verbal communication skills.
• Experience in different environments with autonomy on ambiguous tasks.

Responsibilities

• Get authorised to assess the software lifecycle processes of the most innovative medical devices in the world.
• Create content to explain complex regulatory topics to customers and prospects.
• Screen and action regulatory insights from the latest research, standards and guidance.
• Support the Sales and Customer Experience function by providing regulatory insights on prospects and customers.
• Collaborate with Product, Engineering, and ML teams to optimise processes and scale them.
• Support the Technical Operations function as Scarlet expands approvals in various jurisdictions and technologies.

Skills

Software development

Regulatory knowledge

Written communication

Verbal communication

Autonomy

Problem solving

Education

Bachelor's degree in computer science

Job description

We pull medical technology from the future to solve human health.

Authorised by governments around the world to assess medical AI, we remove unnecessary delays from every regulatory approval we do so patients get devices from the future, today. We are proud to count the world’s most ambitious companies building medical technology as customers. You will be joining a team with product-market fit, flowing data, and exponentially growing revenue.

About this role:

Scarlet’s Devices function is a team of clinicians, AI experts, and software engineers, working together to assess and certify the most innovative and impactful medical device software.

We pride ourselves on delivering fast and efficient assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices.

As we continue to scale our activities and certify more and more medical devices, we need software expertise to provide support across all stages of the customer journey.

You’ll join a team of software experts, conducting swift and accurate device assessments, whilst providing knowledge and expertise to internal functions and external stakeholders.

What you’ll do:

• Get authorised to assess the software lifecycle processes of the most innovative medical devices in the world

• Create content to help explain complex regulatory topics to customers and prospects

• Screen and action regulatory insights from the latest research, standards and guidance

• Support the Sales and Customer Experience function by providing regulatory insights on prospects and customers

• Collaborate with our Product, Engineering, and ML teams to optimise our processes and continue to scale them

• Support the Technical Operations function as they expand Scarlet’s approvals in various jurisdictions and technologies

Who you are:

• You’ve got a degree in computer science or related discipline

• You’ve spent 4+ years in medical device (or other safety critical product) manufacturing, auditing or research, including 2+ years of safety-critical software development experience

• You have practical experience with software development fundamentals, including software development life-cycle processes, software verification and validation testing, software configuration management and cybersecurity

• You like going down rabbit holes, understanding deeply how things work, and challenging the status quo

• You have exceptional written & verbal communication skills

• You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks

Desirable skills:

• Guidance knowledge - You have knowledge or training in the relevant standards and guidance relevant for medical device software (e.g. IEC 62304, IEC 81001-5-1)

• AI fluent - You have strong technical knowledge of modern generative AI (e.g., LLMs, embeddings, RAG, fine-tuning, evaluation/monitoring) and have a rich understanding of how these systems work - and where they fail

The interview process

1. Intro chat with Hann - 30 mins

2. Interview with Sandy and a member of Devices - 30 mins each

3. Technical task & interview with Hann - 1 hour

4. Culture and values interview with James and Jamie - 30 mins each

5. Referencing & offer