Regulatory Data Manager for AI for Health Initiatives — EPFL
NewCHF 83'500 - 126'500
EPFL · Lausanne (VD)
- Location
- Lausanne
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 83'500 - 126'500
Role overview
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.
- Mission
- The EPFL Al Center focuses on advancing research, education and innovation in Al at EPFL and beyond.
- 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
Main responsibilities
- 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.
Application process
- Please note that only applications meeting the criteria of the advertisement will be considered.
Company and context
- 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 Excel
Additional details
- 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
- 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.
- Capabilities for managing several projects at once and meeting deadlines
Notes and original content
- 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
