Product Reviewer - Contractor

Job description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Product Reviewer – Contractor based in Saudi Arabia. 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.

Requirements

• 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 a 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.

Skills