Medical Device Software Compliance 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

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.