成都招聘

This Regulatory Affairs Specialist, China will support Accuray’s product regulatory affairs strategy to obtain medical device pre-market regulatory approvals and ensure ongoing market access for Accuray products and services in China. This position authors regulatory submissions for China and supports Accuray’s third-party entities, such as Accuray’s Joint Venture. He/she must be vigilant to monitor Regulatory Intelligence in China and incorporate regulatory requirements into product requirements and process. In addition, he/she will support ongoing post-market activities such as Recall and Correction & Removal Reporting for Accuray products. Also, he or she has to contribute to the continuous improvement of the regulatory affairs function through projects and support.
1. REPORTING TO/DEPARTMENT:
This position reports to the Manager, Accuray Regulatory and Quality, Asia Pacific Region. The work location is in Shanghai or Beijing, China.
2. ESSENTIAL DUTIES AND RESPONSIBILITIES:
? Prepare, submit, and manage regulatory applications required for product market approvals in China.
? Prepare, submit, and manage Technical Files in compliance with Chinese requirements of the local regulatory and the Accuray Quality Management System.
? Maintain procedures and templates for product development to deliver compliant products and support document to streamline product submissions for China.
? Function as a Regulatory Affairs subject matter expert on new product introduction to China.
? Support Clinical Affairs, engineering, risk management specialist, to ensure clinical studies 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.
? Represent recall activities, progress, and closure to regulatory agencies in China.
? May prepare documentation and reports to interpret Chinese regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
? Manage product controls for quoting, ordering, and shipping medical devices for China.
? Execute facility registrations and submission plan for China to maintain access. Assist with local FDA facility inspections, Notified Body audits and other governmental inspections.
? Support document legalization activities.
? Assist as needed in other activities within the Accuray Regulatory and Quality (ARQ) Department.
3. REQUIRED QUALIFICATIONS:
Required:
? 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 in Regulatory Affairs experience in medical devices NMPA submissions and approvals (especially medical device capital equipment, products containing software, and electro/mechanical components)
? Solid working knowledge and experience of the China regulations and standards applicable to medical device market approval.
? Experience translating Chinese requirements into product requirements and QMS process.
? Proven track record approving and maintaining medical devices with China’s NMPA.
? Proficiency in working through third-parties to obtain China market licenses and approvals.
? Excellent verbal and written English and Chinese(Mandarin) communications skills; strong attention to detail and excellent organization skills
? Excellent organizational skills and attention to regulatory submission details.
? Collaborative, strong interpersonal skills and cross-cultural competency to enable building trusting relationships across functions and geographies.
Preferred or Desired:
? Successful NMPA approvals with Radiation Therapy, Diagnostics Imaging, Surgical Robotic or other medical capital equipment.
? Experience interacting with NMPA on behalf of international companies.
? Self-motivated, self-directing, strong attention to detail and excellent time management skills.
? Demonstrated computer skills including spreadsheets, word processing, e-mail, database, internet research and other applicable software programs.
? Proficiency in working through third parties to obtain market clearance in Asia Pacific countries.
? Experience in project management.
职能类别：
医疗器械注册

安科锐公司总部座落在美国加利福尼亚州的阳光谷，是世界领先的放射肿瘤设备公司。安科锐专业从事先进的放射治疗解决方案的开发和销售，其解决方案可用于治疗各种从最普通到最复杂的癌症。安科锐两项核心的技术——射波刀系统和TomoTherapy系统——树立了一个行业的高标准，以致力于帮助病人更长久更高质量的生活。到目前为止，在全球已经有20万病人接受了公司所提供的治疗方案，有550套系统安装在全球领先的医疗机构里。
安科锐加速器技术（成都）有限公司成立于2005年。公司主要研发和生产医用直线加速器，用于安科锐的TomoTherapy系统中。该加速器可以产生外部的辐射束，有助于生成对肿瘤大小，形状，位置及密度准确定位的图像，同时直线加速器能够对身体需要治疗部位发射螺旋状治疗射线，以便对患处进行360度全方位治疗。2012年6月，公司被安科锐公司授予”全球卓越运营奖”。