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EPFL, the Swiss Federal Institute of Technology in Lausanne, is one of the most dynamic university campuses in Europe and ranks among the top 20 universities worldwide. The EPFL employs more than 6,500 people supporting the three main missions of the institutions: education, research and innovation. The EPFL campus offers an exceptional working environment at the heart of a community of more than 18,500 people, including over 14,000 students and 4,000 researchers from more than 120 different countries.
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
#J-18808-Ljbffr
EPFL, the Swiss Federal Institute of Technology in Lausanne, is one of the most dynamic university campuses in Europe and ranks among the top 20 universities worldwide. The EPFL employs more than 6,500 people supporting the three main missions of the institutions: education, research and innovation. The EPFL campus offers an exceptional working environment at the heart of a community of more than 18,500 people, including over 14,000 students and 4,000 researchers from more than 120 different countries.
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
#J-18808-Ljbffr
Kontaktdaten:
École polytechnique fédérale de Lausanne, EPFL Recruiting-Team
