We are seeking a Senior Documentation & Evidence Control Lead to take ownership of evidence management, traceability, and documentation quality across a cutting-edge AI programme in the Medical Domain.
This is not a junior documentation or administrative role. We are looking for a senior professional who can ensure the organization is always able to substantiate its technical, clinical, and regulatory claims. You will act as the central point of control for evidence, documentation, configuration traceability, and audit readiness across AI models, datasets, software, and governance processes.
This role sits at the intersection of AI, software development, quality management, regulatory compliance, and medical device governance.
- Maintain end-to-end traceability across:
- Source code repositories (GitHub)
- AI model artefacts and releases
- Prompt libraries and prompt usage records
- Datasets and dataset versioning
- Evaluation outputs, reports, and dashboards
- Establish and maintain a structured evidence repository supporting technical and regulatory audits.
- Ensure complete linkage between requirements, development activities, validation results, and released versions.
- Drive documentation quality and completeness across engineering, clinical, and governance functions.
- Ensure documentation is maintained either:
- within repositories and codebases, or
- as controlled external documentation.
- Identify documentation gaps and coordinate remediation activities with relevant stakeholders.
- Implement and maintain documentation standards, templates, and review processes.
- Verify alignment of software and AI artefacts with internal quality requirements and industry best practices.
- Support compliance with applicable regulations and standards, including:
- MDR
- FDA requirements
- GDPR
- EU AI Act
- Data Act
- Responsible AI commitments
- Software quality principles such as ISO/IEC 25010
- Maintain evidence supporting:
- model performance claims
- bias and fairness assessments
- change management activities
- release decisions
- monitoring and post-release controls
- Act as the authority on evidence readiness and traceability.
- Challenge unclear processes, identify risks, and drive improvements.
- Coordinate with engineering, clinical, regulatory, quality, and governance teams.
- Support internal reviews, external audits, inspections, and regulatory submissions.
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
