Job description

Join us today and make a difference in people‘s lives! Liva Nova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol ‘ LIVN .‘ Liva Nova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide. Position Summary: The AI/ML Specialist will be accountable for designing, developing, validating, and maintaining AI/ML solutions that meet healthcare and medical device regulatory requirements. By leveraging state-of-the-art analytical, statistical, and programming methodologies, this role will ensure that deliverables are on time, of high quality, and compliant with applicable regulations. In close collaboration with cross-functional teams-including Regulatory Affairs, Clinical, R&D, and other Data Scientists-this individual will play a pivotal role in guiding regulatory strategies, shaping product roadmaps, and achieving timely regulatory approvals for AI/ML-based products. The AI/ML Specialist has a global scope and supports all business units. General Responsibilities: Provides AI/ML expertise in medical-use algorithm development & validation and works hands-on on medical-use algorithm development projects across the company‘s business units. Contributes to the product strategies and execution for clinical validation and regulatory submissions. Ensure deliverables adhere to regulatory requirements (e.g., FDA, EU notified bodies) by preparing evidence packages and technical documentation for AI/ML solutions. Collaborate with Regulatory Affairs to align AI/ML development plans with current and emerging global regulations for medical devices and digital health. Work with R&D, Clinical, and other stakeholders to identify potential risks, clarify data science requirements, and ensure that AI/ML products meet user needs. Translate complex AI/ML and data science concepts into clear, concise presentations for both technical and non-technical audiences. Analyze clinical and non-clinical data, including real-world evidence and post-market surveillance. Apply predictive modeling, machine learning, and artificial intelligence methods to generate insights and support decision-making for various business units. Serve as an internal consultant on cutting-edge data science methodologies and best practices, encouraging a culture of continuous improvement and innovation. Mentor and train colleagues on regulatory considerations, AI/ML development life cycles, and data-driven decision-making. Maintain compliance with internal procedures (e.g., traceability of changes, data specifications, analysis validation) and the company‘s quality management system. Perform other tasks as per line management discretion. Skills and Experience: 6+ years of experience in AI/ML, data science, or related fields, with a track record of deploying solutions in a regulated healthcare or medical device environment. Previous experience with successful regulatory & clinical strategies to obtain US FDA (or equivalent) approvals of new AI/ML medical-use algorithms. This experience may come either from direct experience at FDA or from several successful applications approved/cleared by FDA. Adaptable to evolving regulatory landscapes, ensuring that AI/ML solutions remain both innovative and compliant. Proven track record in designing and implementing ML/AI solutions. Advanced proficiency in analytics programming languages such as R, Python, SQL, and familiarity with SAS. Traditional Machine Learning: Time series analysis, unsupervised anomaly detection, analysis of high-dimensional data. Mastery of contemporary data science techniques (e.g. deep learning, reinforcement learning, generative models, and NLP), tools (e.g. Azure Cloud environment), and best practices, with a track record of delivering high-impact solutions including regulatory…

Requirements