Product Reviewer (Medical Device Software)

Location: Fully remote with flexible scheduling, subject to assessment demand and availability.

Company

hirify.global assesses and certifies medical devices by combining clinical, technical and regulatory expertise with AI agents and software.

What you will do

• Assess manufacturers’ software lifecycle processes and technical documentation for medical device software, including SaMD and AI-enabled devices.
• Apply EU MDR, UK MDR, IEC 62304, IEC 82304-1, IEC 62366-1 and IEC 81001-5-1 requirements.
• Raise and close technical assessment findings with manufacturers, explaining requirements clearly and constructively.
• Deliver consistent, high-quality assessments aligned with hirify.global’s methodology, values and tooling.
• Work independently with minimal oversight using hirify.global’s assessment workflows.

Requirements

• Bachelor’s degree or higher in software engineering, computer science, electrical/electronic engineering or a closely related field.
• At least 4 years of professional experience in the medical device industry or another safety-critical sector, including at least 2 years designing, developing or testing safety-critical software.
• Prior 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, including IEC 81001-5-1 and MDCG 2019-16.
• Practical experience with software lifecycle processes, verification and validation testing, configuration management and cybersecurity.
• Experience interpreting and applying regulatory requirements to software technical documentation and delivering consistent, high-quality assessments.
• Experience assessing software as a medical device (SaMD).
• Ability to explain findings and requirements clearly and constructively in writing and verbally.
• Willingness to adopt hirify.global’s values, assessment methods and tooling.

Nice to have

• Experience assessing AI/ML-enabled medical devices.
• Practical experience with generative AI, including LLMs, embeddings, RAG, fine-tuning and evaluation or monitoring.
• Familiarity with MDCG 2019-11 and MDCG 2020-1 guidance.

Culture & Benefits

• Contractor engagement with fully remote work.
• Flexible scheduling based on assessment demand and reviewer availability.
• Independent work using defined assessment workflows, methodology and tooling.

Hiring process

• 20-minute introductory call with Guni.
• Two product reviewer competence and regulatory interviews lasting 30–45 minutes each.
• Offer and references.