Senior Regulatory Affairs Specialist
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.
Job Description
Company Statement:
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 Senior Regulatory Affairs Specialist is responsible for expanding the reach of Accuray ’s medical device products in global markets by defining and executing regulatory strategies that enable timely registrations, approvals, and ongoing compliance. This role partners with cross-functional teams across the product lifecycle supporting new product introductions, design changes, and post-market compliance activities including vigilance and reporting. The Specialist provides proactive regulatory intelligence and practical guidance to continuously improve processes and ensure Accuray ’s products meet applicable international and country-specific regulatory requirements.
REPORTING TO/DEPARTMENT:
Reports to the Accuray head of Regulatory Affairs for Asia Pacific region. The work location is remote based on the supported markets.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Prepare, submit, and maintain regulatory applications for premarket approvals and licenses in designated countries.
- Develop and execute regional regulatory strategies and submission plans aligned to business objectives, timelines and risk.
- Represent Accuray with global device regulatory authorities for registrations, regulatory inquiries, reporting, and recalls.
- Engage and manage regulatory agents or authorized representatives across multiple countries.
- Create and maintain technical documentation (e.g., South Korea, Taiwan, Indonesia, Malayasia, Vietnam, Philippines using EU Technical File/Design Dossier, STED) across the product lifecycle in compliance with international and country-specific requirements.
- Develop, maintain, and improve regulatory procedures, templates, and submission tools to streamline registrations and change management.
- Provide regulatory intelligence and interpret evolving regulations and standards to support QMS processes and ensure compliant product development, labeling, and post-market activities.
- Serve as a Regulatory Affairs subject matter expert on cross-functional teams (R&D, Quality, Clinical, Manufacturing, Service, Marketing) to support product launches and sustaining.
- Assess regulatory impact of design, manufacturing, software, and labeling changes; determine submission/reporting requirements and coordinate execution with stakeholders.
- Support commercial readiness activities by maintaining product registration status and regulatory constraints