Job Description

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. ESSENTIAL DUTIES AND RESPONSIBILITIES Prepares and maintains Device Master Files for CDSCO mandatory registration (India MDR 2017) of Accuray products. Includes ability to talk to CDSCO Drugs Controller where needed. Includes, where needed, support to Accuray customers seeking for their own registration based on Accuray data. Prepares and maintains AERB applications for NOCs (Non-Objection Certificate) and TAs (Type Approval) for licensing of Accuray products. Includes communication with customers where needed. Includes support as needed during AERB type inspections. Includes vigilance reporting to AERB as needed. Meets with Regulatory bodies as needed Maintains awareness and expertise on existing and emerging regulations, relevant standards or guidance documents applicable to Accuray products in India, provide interpretive assistance as needed. Prepares and submits product applications necessary to obtain product clearance in EMEA direct markets (marketing approval for existing products in new markets, renewals, marketing approval for product changes in existing markets) Coordinates with and follows closely on Distributors submissions in EMEA indirect marketing territories by providing data to support pre-market submissions to local governments. Manages to file and maintain documented evidence that Distributors have all authorizations to trade Accuray products within their geographies. Supports the Sales Operations team in providing requested Regulatory Information for tender applications. Participates in internal or external audits as required. The incumbent may be asked to perform other function-related activities within EIMEA ARQ matrix organization in addition to the above-mentioned responsibilities as reasonably required by business needs. Required Qualifications BS degree or equivalent in sciences. An advanced technical degree is a plus. Suitable work experience in a technically related field may be considered in lieu of formal education At least 2 years\' industrial experience in the areas of Regulatory Affairs or Regulatory Compliance; gained in the areas of Medical Devices or Capital Equipment (radiation devices a plus) Excellent verbal and written communication skills; must be fluent in English. Must be able to clearly explain local requirements and analyze potential impact on Accuray business Proficiency in working through third parties to obtain market clearance in other countries Excellent organizational skills, strong attention to detail Readiness to solve regulatory-related issues in the Accuray operations Positive attitude, patient, hands-on, persevering Experience in the use of PC\'s and typical software applications including Word, Excel, Outlook, database packages is desired (e.g. OneDrive, Smartsheet) Ability to travel domestically and internationally up to 10% of time. 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.

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