Regulatory Affairs Sr. Specialist - Clinical Usability

Job description

About Radformation Radformation is transforming the way cancer clinics deliver care. Our innovative software automates and standardizes radiation oncology workflows, enabling clinicians to plan and deliver treatments faster, safer, and more consistently, so patients everywhere can receive the same high-quality care. Our software focuses on three key areas: We are a fully remote, mission-driven team united by a shared goal: to reduce cancer’s global impact and help save more of the 10 million lives it claims each year. Every line of code, every product release, and every customer interaction brings us closer to ensuring treatment quality never depends on geography. - Time savings through automation - Error reduction through automated systems - Increased quality care through advanced algorithms and workflows Why This Role Matters: As a Senior Regulatory Affairs Specialist, you will play a key role in ensuring Radformation's Software as a Medical Device products meet global regulatory requirements related to usability engineering and clinical reporting. You will bring a deep expertise in SaMD regulatory expectations, including FDA guidance on applying human factors and usability engin...