Remote Product Reviewer — Medical Device Software

Scarlet; Greater London; Remote; GBP 124,000 - 165,000; Part time

Job summary

Scarlet is seeking a Product Reviewer for software in medical devices. This contractor role focuses on efficient, high-quality assessments of software documentation under EU MDR and UK MDR, with autonomy and strict adherence to Scarlet's methodologies.

You will review lifecycle processes, raise findings clearly, and work remotely with flexible scheduling to match assessment demand, ideal for experienced professionals in regulatory software standards.

Qualifications

• Bachelor's degree or higher in software engineering, computer science, electrical/electronic engineering or related field.
• Minimum 4 years in the medical device industry or safety-critical sector, incl. 2 years designing, developing or testing safety-critical software.
• Prior work as a Product Reviewer for software devices under EU MDR/UK MDR (notified/UK approved body).
• Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1 and software cybersecurity (IEC 81001-5-1).
• Experience with software lifecycle processes, verification and validation testing, configuration management and cybersecurity.
• Evidence of applying regulatory requirements to software documentation.
• Experience assessing software as a medical device (SaMD).
• Ability to explain findings clearly in writing and verbally.
• Ability to deliver assessments independently with minimal oversight.
• Willingness to adopt Scarlet's values, methods and tooling.

Responsibilities

• Assess software lifecycle processes and technical documentation for medical device software under EU MDR/UK MDR.
• Raise and close out technical assessment findings with clear, constructive explanations.
• Deliver consistent, high-quality assessments aligned with Scarlet's methodology and values.

Skills

4+ years in medical device industry

Product Reviewer experience

Regulatory knowledge (IEC 62304, 82304

Software lifecycle, V&V, configuration

Regulatory documentation experience

SaMD assessment

Communication skills

Independent work

Adaptability to Scarlet methods

AI/ML in medical devices

Generative AI / LLMs familiarity

MDCG guidance familiarity

Education

Bachelor's degree or higher in software engineering / computer science / EE

Job description

Scarlet is seeking a Product Reviewer for software in medical devices. This contractor role focuses on efficient, high-quality assessments of software documentation under EU MDR and UK MDR, with autonomy and strict adherence to Scarlet's methodologies.

You will review lifecycle processes, raise findings clearly, and work remotely with flexible scheduling to match assessment demand, ideal for experienced professionals in regulatory software standards.