Senior Regulatory Affairs Specialist

Accuray

1d•Remote

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.