上海招聘

• Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely.
• Interact with CFDA on registration requirements and monitor changes to requirements.
• Independently manages and monitors multiple complex and diverse short term and long-term projects without direct supervision. Interacts with manager as required by specific issues, milestones, or status changes.
• Manages the regulatory review of labels, labelling, clinical protocols, and clinical reports for products that are under his/her responsibilities.
• Ensures compliance with regulatory requirements, including but not limited to change management, Chinese labelling requirements, etc.
• Monitors regulatory and Standards developments affecting DentsplySirona product he/she is responsible for.

任职要求：

• Bachelor’s degree or above in related scientific discipline; Medical or pharmaceutical back ground is preferred. 
• With a minimum 2 years regulatory experience as RA function in medical device industry.
• Ability to think strategically, to detect the essence of complex or ambiguous issues, and to put these in the context of larger, systemic issues.

• Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers

• Interprets subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.

• Basic communication skills in English.

            

登士柏西诺德（NASDAQ: XRAY）是一家牙科解决方案公司，提供专业的牙科耗材，设备，技术和其他专业产品。包括CAD/CAM全瓷修复系统(CEREC)，X线影像系统，口腔综合治疗台，治疗器械，消毒系统，以及根管，修复，技工和种植领域的专用产品和耗材的研发，生产和销售。
公司成立于2016年，源自于美国登士柏和德国西诺德公司的对等合并。基于各自100多年的历史，两家企业均在牙科产品，技术研发和数字化治疗方面为全世界树立了标杆，如今作为一家企业也将这个优势延续下去。登士柏西诺德是牙科诊所，医院，技工所和授权经销商赖以依赖的合作伙伴。
登士柏西诺德全球总部位于美国北卡罗来纳州夏洛特，公司在全世界40多个国家拥有约15,000名员工，在120多个国家拥有销售机构。
登士柏西诺德在中国有超过600名员工，其中上海是登士柏西诺德中国总部。此外，在北京，深圳，广州，杭州，南京，成都，西安，沈阳，济南，太原等地均设有办公室。