上海招聘

职位描述：
亚太区法规事务专员 ( Regulatory Affairs Specialist, Asia Pacific)
Job Description
The Regulatory Affairs Specialist, Asia Pacific obtains medical device pre-market regulatory approvals to ensure market access is realized for Accuray products and services in Asia Pacific. This position authors regulatory submission in Asia Pacific through third party entities. He/she must be vigilant of developing standards and regulations and their impact on Accuray product clearances. In addition, he/she will handle post-market agency reporting activities ie. Asia Pacific Medical Device Reports(MDR)，Recall and Correction & Removal Reporting.

Responsibilities
? Prepare, submit, and manage regulatory clearance applications required for product market approvals in Asia Pacific .
? Prepare, submit, and manage Asia Pacific Design Dossier/Technical Files in compliance with the requirements of the local regulatory and the Accuray Quality Management System.
? Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
? Assist research personnel, application specialist, risk management specialist, to ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements.
? Participate as subject matter expert in internal and external quality system and design dossier audits
? Gather and prepare materials to enable Medical Device Reports, Vigilance, Adverse Events, Recall, etc. decision making process
? Collate and prepare all materials, reports and follow-up with Regulatory Agencies regarding recall activity.
? May prepare documentation and reports after interpretation of Asia Pacific countries regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
? Support Post Market Surveillance activities i.e. Complaint Investigations, MDR, etc.

Requirements

? Qualified applicants must have a Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry
? Minimum of 3 years’ Regulatory Affairs experience in medical devices (especially products containing software and electro/mechanical components
? Solid working knowledge of the Asia Pacific regulations and standards applicable to medical device market clearance.
? Proven track record clearing medical devices to market in Asia Pacific.
? Proficiency in working through third parties to obtain market clearance in Asia Pacific countries.
? Excellent verbal and written English and Chinese communications skills; strong attention to detail and excellent organization skills
? Experience in project management preferred 举报 分享

Accuray Incorporated (Nasdaq: ARAY), based in Sunnyvale, Calif., is the premier radiation oncology company. The company develops, manufactures and sells personalized, best-in-class treatment solutions that revolve around the patient. Accuray’s innovative technologies – the CyberKnife and TomoTherapy Systems – set the standard of care with the aim of helping patients live longer, better lives.
Accuray是一家放射肿瘤治疗公司，致力于发展、生产及销售引领医护标
准的个人化、创新治疗解决方案，旨在延长患者的寿命及提高他们的生
活质量。本公司的先进技术提供全方位的放射治疗和放射手术治疗。

我们的理念：
开创一个新的未来，让癌症患者不再遭受恐惧和痛苦。
我们的使命：
制定个人化、先进的治疗解决方案，延长患者的寿命及提高他们的生活质量。
我们的治疗方案的重要性：
患者–Accuray透过创新，延长癌症患者的寿命及提高他们的生活质量，为他们带来新的希望。
客户–Accuray的先进治疗解决方案提高了医疗机构的临床治愈机会，帮助他们为每一位患者提供最好的治疗。
投资者—Accuray提供专门用于影像导引放射手术和调强放射治疗的独特产品，这两个市场分部正在快速增长。
员工——Accuray员工致力于从根本上改变癌症治疗方法的未来，延长患者的寿命并及提高他们的生活质量。