亚太区法规事务专员 上海

月薪： 1-1.5万/月

该公司所有职位
  • 3-4年经验
  • 本科
  • 招1人
  • 11-09 发布
  • 五险一金
  • 补充医疗保险
  • 专业培训
  • 绩效奖金

职位描述

职位描述： 亚太区法规事务专员 ( Regulatory Affairs Specialist, Asia Pacific)Job DescriptionThe 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 职能类别： 医疗器械注册

联系方式

虹梅路1535号星联科研大厦1号楼616室

公司信息

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。

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