高级法规事务专员

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 for quoting, ordering, distribution, and shipment of medical devices.

• Support internal and external audits, inspections, and document legalization as needed.

CORE COMPETENCIES:

• Professional Excellence
• Communicates clearly and effectively with internal stakeholders and regulatory bodies.

• Demonstrates professionalism, judgment, and integrity.

• Strengthening the Team
• Collaborates effectively with global, cross-functional teams and influences without authority.

• Takes ownership of deliverables, proactively manages priorities, and escalates risks early.

• Demonstrates initiative and a continuous-improvement mindset.

• Drive for Results
• Makes timely, high-quality decisions using sound business judgment and appropriate risk-based thinking.

• Maintains deep working knowledge of applicable regulations and standards within assigned regions/scope.

• Builds alignment and drives collaboration to achieve shared objectives.

REQUIRED QUALIFICATIONS:
· Required:
· Bachelor’s degree in a scientific, engineering, or related discipline (or equivalent experience).

• 7+ years of experience in Regulatory Affairs or Quality Assurance within a medical device development and manufacturing environment.

• Demonstrated experience authoring and leading regulatory submissions for medical devices in major markets (e.g., U.S., EU, China, Japan).

• Strong working knowledge of international medical device regulations and dossier frameworks (e.g., IMDRF, EU MDR, ASEAN, EAEU; STED/Essential Principles).

• Working knowledge of ISO 13485 and MDSAP with experience supporting audits/

• Proven track record partnering cross-functionally and globally to deliver results in a matrixed environment.

• Excellent written and verbal communication skills; experience communicating with health authorities in writing and in live meetings.

• Strong organizational skills and attention to detail, with the ability to manage multiple priorities and timelines.

• Strong interpersonal and cross-cultural skills; builds trust and effective working relationships across functions and geographies.

• Ability to travel occasionally, domestically and internationally, as business needs require.

• Preferred or Desired:
• Master’s or PhD in regulatory science, engineering, life sciences, or business.

• Experience managing regulatory projects and timelines (formal project management training/certification a plus).

• Experience with radiation therapy or radiological imaging products.

• Experience with post-market vigilance requirements (e.g. adverse event reporting, complaint support, field safety corrective actions/recalls).

• Demonstrated knowledge of regional submission pathways and lifecycle requirements across multiple global medical device authorities.

• Knowledge of ISO 14971 risk management and medical device safety/performance standards for medical devices.

WORKING CONDITIONS
· Indoor Environment: The position takes place indoors, providing a comfortable and climate-controlled workspace

• Sedentary Work: This role involves extended periods of sitting and working at a desk, requiring good ergonomic practices

• Computer Usage: Proficiency with computers, including software applications and communication tools, is essential for tasks and collaboration

• Minimal Physical Strain: While physical demands are generally low, occasional light lifting and moving of objects might be required

• Structured Schedule: This position usually follows regular business hours, promoting a consistent and predictable work routine

To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.
EEO Statement
At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top — and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin – including individuals with disabilities and veterans.
Originally posted on Himalayas