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.
Studies-Experience:
• 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: Windsor Search Consultants LLC
• 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).
Job based in USA (Salt Lake City)
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