Principal Regulatory Specialist, AI/ML Projects

Description A Career at Clarius Today, as many as 25 million medical professionals globally don’t have access to medical imaging, which is proven to improve patient care and reduce healthcare costs. That’s why we’re on a mission to make medical imaging accessible everywhere by delivering high-performance, affordable, and easy-to-use solutions powered by artificial intelligence and connected to the cloud. By making Clarius your next career move, you’re joining a team of 140+ people who are talented, innovative, and highly collaborative. You’re also joining a community that includes thousands of physicians worldwide who use Clarius to deliver better patient care! And you’re joining a thrice-certified Great Place to Work! Your Role We're seeking an experienced Regulatory Specialist to support our Data Science and Regulatory Affairs teams in defining and executing regulatory strategies for AI/ML-enabled medical devices. You'll need deep expertise in the regulatory landscape for AI/ML devices, including AI/ML design and development methodologies, SaMD requirements, and the software development lifecycle. Over the next 24 months, your primary responsibilities will be translating complex machine learning concepts into clear, precise regulatory documentation including DHF creation, regulatory submission preparation, and related data documentation. This is a two-year fixed-term contract. Your Responsibilities Include: Collaborate with ML engineers and RA team to define and execute reg