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5-7年经验 -
招1人 -
02-03 发布
职位描述
职责描述： 1. Identify, prioritize and coordinate process improvement initiatives to improve the speed and cost effectiveness of the Greater China RA organization, while maintaining quality levels required for medical device development and support.2. Responsible for maintenance of RA procedures, work instructions, and/or job aids in coordination with the process owners.a. Support departmental audits and responses to audit findings. b. In cooperation with R&D QA, ensurei. Quality throughout the RA organizationii. Compliance with Health Authority and company regulations and guidelinesiii. Adequate training for all processesiv. Audit inspection readiness3. Support development, implementation, and maintenance of RA metrics to help drive performance.4. Identifies opportunities to improve quality, reduce cycle time, and increase operational efficien-cy. Leads the planning and execution of high-impact process improvement projects5. Manage greater China regulatory budget effectively.任职要求：Education : University degree in Medical ScienceAdvanced degree in Medical Sciences preferredFormal training in Process Improvement Methodologies preferred (e.g. six sigma)Fluent English (oral and written)Knowledge/Fluency of at least one additional language preferredExperience: 5+ years of industry experience (ophthalmic and/or medical device experience preferred)3+ years of experience in regulatory processes including Health Authority submissions.Good knowledge and broad experience in Regulatory Affairs operations and associated relevant guidelines and regulationsStrong problem solving skills. 职能类别： 医疗器械注册
联系方式
新恒基国际大厦12楼
公司信息
爱尔康（中国） 作为全球眼科领域的领导者，爱尔康的使命是通过创新型产品，提高视觉质量，提高生活品质。这个使命意味着爱尔康22000多名员工为“保护、恢复和提高视力”的目标进行着不懈的努力与奋斗,使散光治疗，青光眼治疗，近视眼激光视力恢复矫正等等技术得到更好，更全面的普及，努力改善更多人的视力健康。 诺华和爱尔康合并后，爱尔康、视康和诺华眼科的优势融合到同一眼科保健业务，爱尔康已成为诺华集团第二大业务部门。公司合并带来的整合资源和业务覆盖的优势，爱尔康现在180个国家销售全线的眼科保健产品，包括手术产品、药品和视力保健产品，并在75个国家拥有分公司。 从一个孩子为矫正近视眼配的第一副隐形眼镜，到她的祖父母为治疗白内障而做的人工晶体植入，爱尔康的创新产品帮助各个年龄段的患者更清晰地看到世界。爱尔康的产品与高科技可用于解决诸多领域里日益增长的临床问题，例如白内障、青光眼、视网膜疾病、屈光不正、眼部过敏、眼部干涩、感染和发炎以及许多其他眼部护理需求。 在全球范围内，爱尔康有近2000名员工致力于研发工作，以满足世界上最迫切的眼部护理需求。同时，我们的业务也延伸到专业教育领域并在整个行业内处于领先水平。
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