Product Reviewer – Contractor

AustraliaRemoteContractmid

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Quick Summary

Key Responsibilities

Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices. Evaluate compliance with EU MDR, UK MDR, IEC 62304,

Technical Tools

Other

As a Product Reviewer, you will independently assess the technical documentation and software lifecycle processes of medical device software, including Software as a Medical Device (SaMD) and AI-enabled solutions. You will help ensure that innovative healthcare technologies meet rigorous regulatory, technical, and safety requirements. Working with manufacturers, you will evaluate compliance with European and UK medical device regulations and relevant international standards. You will communicate assessment findings clearly and constructively, supporting manufacturers in addressing technical and regulatory gaps. This fully remote contractor opportunity offers flexible scheduling based on assessment demand and availability. You will contribute to maintaining high standards of medical device safety while helping accelerate the development and certification of advanced healthcare technologies.

In this role, you will independently deliver accurate, consistent, and high-quality technical assessments of medical device software documentation. Your responsibilities will include:

Assess manufacturers' software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices.
Evaluate compliance with EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1, and IEC 81001-5-1.
Review software development and lifecycle documentation to verify that applicable regulatory and technical requirements are met.
Identify, document, communicate, and follow up on technical assessment findings with manufacturers.
Explain regulatory requirements and assessment findings clearly and constructively, both verbally and in writing.
Work with manufacturers to clarify technical issues and close out assessment findings.
Deliver consistent, efficient, and high-quality assessments in accordance with established methodologies, standards, and values.
Apply independent judgment when evaluating technical documentation and regulatory compliance, with minimal supervision.
Adopt established assessment workflows, tools, and working practices to ensure consistency and quality across reviews.

Requirements

~2 min read

The ideal candidate will have established experience assessing medical device software, a strong understanding of regulatory frameworks, and the ability to deliver independent technical reviews. Required qualifications include:

Bachelor's degree or higher in Software Engineering, Computer Science, Electrical or Electronic Engineering, or a closely related discipline.
At least 4 years of professional experience in the medical device industry or another safety-critical sector.
At least 2 years of experience designing, developing, or testing safety-critical software.
Previous experience as a Product Reviewer or technical documentation assessor for a notified body or UK approved body, covering software devices such as MDA 0315 or MDS 1011.
Working knowledge of IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and medical device cybersecurity requirements, including IEC 81001-5-1 and MDCG 2019-16.
Practical understanding of software development fundamentals, including lifecycle processes, verification and validation testing, configuration management, and cybersecurity.
Demonstrated ability to interpret and apply regulatory requirements when assessing software technical documentation.
Proven track record of delivering consistent, high-quality technical documentation assessments.
Experience assessing Software as a Medical Device (SaMD).
Strong written and verbal communication skills, with the ability to explain technical findings and regulatory requirements clearly and constructively.
Ability to manage assessments independently and deliver high-quality work with minimal oversight.
Willingness to adopt established assessment methodologies, workflows, tools, and professional values.

Experience assessing AI and machine learning-enabled medical devices.
Practical familiarity with generative AI technologies, including large language models (LLMs), embeddings, retrieval-augmented generation (RAG), fine-tuning, and model evaluation or monitoring.
Familiarity with relevant regulatory guidance, including MDCG 2019-11 on software qualification and classification and MDCG 2020-1 on the clinical evaluation of software.