Device Specialist

Scarlet; Greater London; On-site; GBP 55,000 - 75,000; Full time

Job summary

Scarlet is seeking a qualified professional to join its Devices function to audit management systems and assess the technical documentation of advanced medical devices. You will help optimise processes and ensure conformity assessments align with evolving regulatory standards across multiple jurisdictions.

Ideal candidates have a strong background in engineering or medicine, with substantial experience in medical device manufacturing, auditing, or research, and practical knowledge of quality

Qualifications

• Analytical reading of normative texts to extract essential information.
• Rigorous analysis of requirements and standards in medical devices.
• Strong communication of complex regulatory concepts.

Responsibilities

• Get authorised to audit management systems and assess technical documentation of devices.
• Build and optimise auditing and assessment processes for management systems and devices.
• Stay up to date with latest standards and guidance and apply them to assessments.
• Help maintain and expand approvals across jurisdictions and technologies.

Skills

Analytical reader

Ferociously curious

Highly adaptable

Excellent communicator

Education

Bachelor’s degree or higher in engineering/medicine/related 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, software engineers and device specialists, working together to audit, assess and certify the most innovative and impactful medical devices. We pride ourselves on delivering efficient audits and fast technical assessments to enable market access, new device updates and ongoing surveillance of a growing portfolio of medical devices. We are both the designers and operators of our auditing and assessment processes, working with Scarlet's internal team of software developers, product designers, and ML engineers, to develop world‑class tooling to support conformity assessment. We’ve proven our capabilities with medical device software and are actively expanding our scope to include hardware medical devices.

Your responsibilities:

• Get authorised to audit management systems and assess the technical documentation of the most innovative devices in the world
• Build and optimise Scarlet’s processes for auditing and assessing management systems and medical devices
• Stay up to date with the latest standards and guidance, and incorporate them into the assessment process
• Help maintain and expand Scarlet’s approvals in various jurisdictions and technologies

Key skills:

• Bachelor’s degree or higher in engineering, medicine or other relevant science or engineering discipline
• Minimum of four years of professional experience in the manufacturing, auditing or research of medical devices
• Minimum of two years of professional experience in the design, manufacture, testing of medical devices
• Two years of professional experience in the area of quality management.

Desirable skills:

• Analytical reader - You feel comfortable with reading normative texts and analysing and interpreting requirements to extract the essential information
• Ferociously curious - You like going down rabbit holes, understanding deeply how things work, and challenging the status quo
• Highly adaptable - You have worked in different environments and like operating with autonomy on sometimes ambiguous tasks
• Excellent communicator - You have exceptional written & verbal communication skills

The interview process:

• Intro call with Sandy - 30 mins
• Team interviews - 2 x 30 mins
• Technical interview - 1 hour
• Culture and values interview with James and Jamie - 2 x 30 mins
• Referencing & offer