Regulatory Affairs Intern

Accuray • Madison, WI

2d

About The Position

Give hope. Give health. Make your mark in the fight against cancer. At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer — helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world. Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. SUMMARY: The Regulatory Affairs Intern will support the Global Regulatory Affairs organization by driving process improvements, automation, and data-enabled insights across regulatory operations. This role is project-focused and well-suited for a student with an interest in engineering, data science, public policy, or law who wants exposure to how global medical device regulations are operationalized at scale. The intern will work closely with Regulatory Affairs, Quality, Engineering, Clinical Affairs, and IT partners to streamline global regulatory processes, develop AI-enabled tools, and improve the scalability and consistency of regulatory deliverables across more than 80 countries.

Requirements

• Strong analytical and problem-solving skills.
• Ability to work independently with guidance and manage scoped project work.
• Strong written and verbal communication skills.
• Proficiency with standard office software (Word, Excel, PowerPoint, email).

Nice To Haves

• Currently pursuing a degree in Engineering, Data Science, Public Policy/Government, Regulatory Affairs, or Law (including 1L students).
• Interest in medical device regulation, healthcare policy, or regulated product development.
• Exposure to process improvement, data analysis, automation, or AI-enabled tools through coursework, projects, or prior experience.
• Familiarity with documentation, structured data, or workflow tools (e.g., Excel, databases, low-code tools, or similar).

Responsibilities

• Consolidating and structuring global regulatory requirements related to business entity registrations, device certifications, and distribution models (e.g., manufacturer, importer, distributor), and developing scalable tracking, maintenance, and renewal processes.
• Supporting global regulatory change management by translating engineering change impact assessments into structured regulatory actions and country-specific filing requirements across 80+ markets, leveraging existing and emerging AI tools.
• Streamlining and automating regulatory processes across the medical device lifecycle, including Risk Management, Clinical Affairs, and Regulatory reporting, by converting routine regulatory intelligence into repeatable, data-driven workflows.
• Defining standardized data inputs, process flows, and documentation that enable automation, improve consistency, and reduce manual effort across global regulatory activities.
• Partnering cross-functionally with Regulatory Affairs, Quality, Engineering, Clinical Affairs, and IT to understand process dependencies, document current- and future-state workflows, and support change management and adoption through clear documentation and training-ready materials.

What This Job Offers

• Career Level: Intern
• Education Level: No Education Listed
• Number of Employees: 251-500 employees