Senior Regulatory Affairs Specialist - Clinical Usability

📋 Description

• • As a Senior Regulatory Affairs Specialist at Radformation, you will ensure the company's Software as a Medical Device (SaMD) products meet global regulatory requirements for usability engineering and clinical reporting, directly supporting the mission to deliver safer, faster, and more consistent cancer care worldwide.
• • Day to day, you will lead the design and execution of formative and summative usability studies, generate regulatory submission content such as usability plans and reports, map clinical deliverables to global evidence requirements, and collaborate with clinical affairs and product teams to strengthen PMCF/PMS processes and compliance across the product lifecycle.
• • You will join a fully remote, mission-driven team at Radformation, a company transforming radiation oncology through automation, error reduction, and advanced algorithms to ensure equitable access to high-quality cancer care regardless of geography.
• • In this role, you will deepen your expertise in global SaMD regulations, lead critical usability and clinical deliverables for FDA and EU MDR submissions, influence regulatory strategy, and help scale Radformation’s regulatory function as the company grows.