上海招聘

Responsibilities:

• Manages the preparation and submittal of all product applications necessary to obtain marketing approval forproducts in the Chinese market and contribute for product changes in existing markets.

• Act as the liaison between AIS headquarter RA personnel, local regulatory agencies and distributors as required.

• Provide guidance to RA staff and management on the need for a new regulatory application in China. As needed, collect the relevant information and generate the submission dossier, communicate with CFDA as needed to understand the submission requirements (e.g., what documentation, test data, and other supporting information) will be required.

• Assist distributor in non direct marketing territories by providing relative test and technical data to support their regulatory submissions to their local governments.

• Monitor domestic and international regulatory requirements to ensure appropriate compliance to relevant pre market submission requirements.

• Works with regulatory affairs personnel and top management personnel in formulating and establishing company quality policies and goals

• Establishes procedures and policies to ensure that the quality system meets the requirements of national and international regulations

• Manage and support post-market surveillance activities i.e. complaint investigations, Adverse Event & Recalls. Ensure that reports from customers and employees in the respective region regarding alleged safety issues are promptly brought to management’s attention and reviewed

• Manages and coordinate the device vigilance and recall programs, and ensures that they meet the requirements of applicable quality system and regulatory requirements

• Prepares, submits and maintains licensing obligations

• Submits reports as necessary to comply with local and international regulations

• Assists research personnel in ensuring that clinical investigations are undertaken in accordance with the necessary regulatory requirements

• Assists other department and trains employees as needed on regulatory and quality matters

• Prepares for and participates in representing Accuray during external quality system audits

• Contribute and support health authority or certification body inspection

• Drive or support allocated projects within RA/QA.

• Provide expertise in RA/QA matters for the allocated market.

• Periodic reporting and/or presenting of the activities conducted in order to support the organization in the allocated market.

• Travel to Hong Kong

REQUIRED EXPERIENCES & QUALIFICATIONS

· Bachelor’s degree in Business, Engineering, and or Science

· 5+ years of experience working in a regulatory department

· Experience in regulatory filing, correspondence and contacts with regulatory agency

· Experience working in quality assurance preferrable

· Experience working in a medical device company and knowledge of Meddev regulations

· Fluent (oral and written) in English and Mandarin

· Solid working knowledge of applicable national and international health, safety and quality standards

· Knowledge of and experience in internal quality system auditing is desired.

· Proficiency in the use of PC’s and typical software applications including Word, Excel, Outlook, database packages, project management and other applications.

· Excellent communication, organizational and customer relations skills desired.

· Ability to drive process improvement, new business and cost savings initiative.

· Self sufficient with Advanced Microsoft office and ERP databases.

· Excellent communication skills, both written and verbal.

· Strong attention to detail and strong presentation skills highly desirable

· Team player and willingness to learn

· Dealing with ambiguity

· Delivering results and meeting customer expectations

· Priority Setting

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。