东莞招聘

Technical Competencies:
? Knowledge of medical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations
? Knowledge of domestic and international laws, regulations, and guidance that affect assigned devices
? Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
? Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices
? Ability to influence and partner with cross-functional teams in a global CGM organization
? Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
? Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
? Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks
Professional Competencies:
? Demonstrated ability in analytical reasoning and critical thinking skills
? Strong capability to contribute and lead a team environment
? Strong business acumen and ability to see the business drivers outside of Regulatory Affairs 
? Excellent communication skills; both oral and written
? Strong interpersonal skills with the ability to influence others in a positive and effective manner
? Demonstrated ability to contribute to a continuous learning and process improvement environment
? Capacity to react quickly and decisively in unexpected situations 
? Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
? Focused ability to influence operational excellence and performance metrics
? Risk adverse where needed with the ability to identify potential solutions to complex problems

Experience:
? 10+ years relevant medical device industry and regulatory experience
? Glucose monitoring systems regulatory experience highly preferred in global environment
? Bachelor’s degree in science or health related field
? Advanced degree preferred (PhD, MS, or equivalent)

三诺生物传感股份有限公司是一家致力于利用生物传感技术及数智化建立糖尿病等慢病全病程管理的高新技术上市公司，旗下还拥有三诺健康、三诺健恒糖尿病医院等全资子公司。于2002年创立，总部位于中国湖南省长沙市，2012年在深交所上市。2016年收购美国Trividia Health Inc.和美国PTS两家公司，进入全球血糖仪行业领先阵营。
在中国超过50%的糖尿病自我监测人群使用三诺的产品，三诺已成为中国血糖监测产品行业的领导企业，是中国零售市场***的血糖仪制造商；全球拥有5个研发基地，6个生产基地，业务遍布135个国家和地区。
公司产品主要包括血糖、血脂、尿酸、血酮等便携式检测产品；全自动生化分析仪、免疫荧光分析仪、便携式糖化血红蛋白检测仪等慢病相关指标POCT检测系统；以及慢病全病程管理及防治的全方位关爱服务。公司致力于通过构建“硬件+软件+服务”模式，提供智慧医疗解决方案，打造慢病管理生态系统。
因消费者信任及坚持为员工提供成长的平台，三诺生物2018，2019年连续两年获得“中国优秀雇主奖”。在向国际化迈进的道路上，我们需要优秀的海内外人才，经过加速培养体系，跨国轮岗，成为三诺未来的技术专家和国际化管理人才。