Regulatory Data Manager for AI for Health Initiatives
Mission
The EPFL Al Center focuses on advancing research, education and innovation in Al at EPFL and beyond. It is at the core of a vibrant EPFL community and dynamic external ecosystem that includes a large number of partners and stakeholders in Al, including academia, industry, government, and international organisations. We are searching for a Regulatory Data Manager for National Initiatives in AI for Health. The role will support important research initiatives led by the EPFL AI Center, and the Swiss Data Science Center (SDSC). In particular, the new Regulatory Data Manager will be mainly involved in the National AI Initiative for Precision Oncology (NAIPO), which transforms cancer care in Switzerland by integrating advanced AI across the patient journey. It unites hospitals, companies, and startups to drive innovation, reduce healthcare costs, and position Switzerland as a leader in personalised medicine. NAIPO is led by the EPFL AI Center and comprises 31 partners such as universities, cantonal and private hospitals, national research infrastructure such as SDSC and CSCS, universities, private companies such as pharmaceutical companies or start-ups. That main mission will be complemented by an additional role in supporting translational initiatives led by the SDSC.
Please note that only applications meeting the criteria of the advertisement will be considered.
Main duties and responsibilities
You will collaborate with the EPFL AI Center, the SDSC and its clinical partners, the NAIPO Management Support Team, the legal department/office of each partner, the clinical coordinators and the NAIPO members. In the context of NAIPO, you will:
- Coordinate a comprehensive Data Protection Impact Assessment (DPIA) with research, hospital, and legal partners, evaluating privacy risks and mitigation strategies for each subproject.
- Coordinate the drafting of Clinical Study Protocols according to the Swiss Human Research Act and standardized Patient Information and Consent Forms (PICFs).
- Develop a modular Data Privacy Compliance Framework.
- Develop a standard Data Processing and Transfer Agreements (DPAs, DTAs).
- Define an AI model validation guidelines aligned with Swissmedic standards and ISO norms for medical software, ensuring the clinical deployment of AI tools meets regulatory expectations.
- Coordinate with the different legal department / office of each institution.
- Define, maintain and oversee the data management of NAIPO, in close collaboration with the data managers from SDSC and the implementation partners.
- Develop and implement a Regulatory Monitoring Plan to track changes to data protection, AI, and clinical research regulations over the project's lifetime, ensuring adaptive compliance.
- Promoting the EPFL AI Center, managing our extensive partner network, and building our ecosystem in Switzerland and beyond.
Furthermore, in the context of SDSC translational AI for health research projects, you will:
- Support the writing of Data Processing and Transfer and Usage Agreements (DPAs, DTUAs) for Health & Biomedical projects.
- Support to organizations – particularly Swiss SMEs - in the path to SAMD : advise them regarding which types of projects and products explicitly require to undergo the process, and which ones make it highly recommended; advise them on the process and milestones linked to the different SAMD levels.
Profile
- More than five years of professional experience in a clinical regulatory environment and in writing clinical protocols
- Demonstrated expertise of the Swiss regulatory landscape and ethics committees (Swiss Human Research Act, data protection regulations…)
- Experience in negotiating with ethics committees
- Proven ability to translate regulatory requirements into practical operational frameworks for complex, multi-partner projects
- Ability to integrate in highly dynamic environments
- Capabilities for managing several projects at once and meeting deadlines
- Excellent knowledge in English, French and German
- Enthusiastic, resourceful, curious—and excited to work at the intersection of science and society
- Familiarity with Swiss academia or AI-related topics is a plus
We offer
- A dynamic role in a stimulating, intellectually rich environment
- Flexible work hours and remote work possible
- Exposure to cutting-edge science, top researchers, and global conversations around AI and health
Informations
- Contract Start Date : 08/01/2026
- Activity Rate : 70.00
- Contract Type: CDD
- Duration: 1 year, renewable