As part of the Regulatory Affairs Team, we are in search of a RA Data IT Specialist who will act as Regulatory Affairs subject matter expert and support business activities. Main Accountabilities: + Support compliance of our systems and software with applicable regulations and standards applicable to Medical Devices, IVD Medical Devices, Software as Medical Device throughout the product lifecycle. + Support the regulatory teams involved in the regulatory submissions for systems and software on the topics related to cybersecurity, AI/ML, EHDS, UDI among others. + Assist in the development of answers to questions in the interactions/negotiations with regulatory authorities and stay current with regulatory knowledge. + Perform a regulatory watch to identify new requirements applicable and perform related impact assessments. + Assist in the execution and improvement of regulatory processes related to cybersecurity and AI/ML and interactions with internal/external stakeholders. + Participate to external trade associations. + Represent department in transversal company projects that require regulatory input and guidance. Minimum Requirements: + Master’s degree or equivalent in Science or Engineering preferred + 8+ years in regulatory affairs and/or system engineering, or equivalent, medical device/IVD industry preferred. + Expertise in system/software lifecycle development and in particular cybersecurity and AI/ML. + Excellent verbal and written communication skills. + Fluent communication in English. Skills and Qualifications: + Demonstrate success in supporting both growth and product support projects, including complex projects involving ambiguity, in a rapidly changing regulatory and quality environment. + Strong communication skills, both written and verbal, is required. + Ability to influence peers, higher leaders and external expert or regulatory agencies. + Ability to analyze and use data to drive decisions; analyze and understand technical documents and regulatory requirements. + Comprehensive knowledge of regulations and standards applicable to Medical Device/IVD Medical Device. + Knowledge of preparation of dossiers; technical writing skills to develop clear conclusions based on design documentation and to compile dossiers. + Routine problem solving, develop rationale, and propose solutions. + Mobility: Travel as needed (external meetings with the local and corporate teams, trainings).