Documentation & Evidence Control Lead (Medical AI)

TL;DR

Documentation & Evidence Control Lead (Medical AI): Managing evidence, traceability, and documentation quality for a cutting-edge AI programme in the medical domain with an accent on regulatory compliance and audit readiness. Focus on establishing end-to-end traceability between source code, AI models, datasets, and regulatory requirements.

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to over 1000 clients globally with a team of 7,600 people across 60 countries.

What you will do

• Maintain end-to-end traceability across GitHub repositories, AI model artefacts, prompt libraries, and datasets.
• Establish and manage a structured evidence repository to support technical and regulatory audits.
• Drive documentation quality and completeness across engineering, clinical, and governance functions.
• Ensure alignment of AI artefacts with regulatory standards including MDR, FDA, GDPR, and the EU AI Act.
• Act as the central authority on evidence readiness, coordinating with cross-functional teams to identify and remediate documentation gaps.
• Support internal reviews, external inspections, and regulatory submissions.

Requirements

• Senior professional experience in evidence management, traceability, and documentation quality.
• Expertise at the intersection of AI, software development, quality management, and medical device governance.
• Strong knowledge of regulatory frameworks such as MDR, FDA, GDPR, and the EU AI Act.
• Experience with source code repositories (GitHub) and dataset versioning.
• Ability to challenge existing processes, identify risks, and drive governance improvements.

Culture & Benefits

• Opportunity to work on cutting-edge AI programmes within the medical domain.
• International work environment with a global community of experts.
• Focus on nurturing talent and providing steppingstones for professional growth.
• Structured recruitment process with transparent feedback.

Hiring process

• Brief introductory call to align motivations and role expectations.
• Average of 3 interviews with line managers and future teammates to discuss experience and skills.
• Possible case study or technical assessment depending on the specific requirements of the position.