北京招聘

工作职责:

Responsibilities

1. to set up and maintain the clinical quality system to meet regulatory expectations and business need;

2. Manage and recommend changes to existing procedures where applicable;

3. To be expertise of clinical regulations and standards and ensure necessary requirements are transferred and built into internal clinical QMS;

4. Conduct internal training on clinical regulations and clinical QMS;

5. Provide quality check on clinical research essential documents, including protocol, ICF, CRF and study reports;

6. Plan and conduct internal audit;

7. to prepare for the inspections and coordinate inspection response;

8. Support clinical projects on quality issues, if necessary.

任职资格:

1. At least with bachelor degree of medicine/ pharmacy/ other healthcare disciplines;

2. At least 5 years’ experience in clinical research, experience in clinical quality is a plus;

3. Knowledge of local and international regulations, such as ICH-GCP, ISO 14155;

4. Fluent in English speaking, reading and writing;

5. Strong communication skill;

6. Good presentation skill;

7. High attention to detail and accuracy;

8. Able to manage multiple tasks;

9. Able to work effectively with teams.

微创？起源于1998年成立的上海微创医疗器械（集团）有限公司，总部位于中国上海张江科学城，产品已进入全球逾万家医院，是一家领先的创新型高端医疗器械集团，现有员工近6,000名，平均每8秒就有一个微创的产品被使用。
微创？致力于提供能延长和重塑生命的普惠化真善美方案。在中国上海、苏州、嘉兴、东莞，美国孟菲斯，法国克拉马尔，意大利萨鲁贾和多米尼加共和国等地均建有主要生产（研发）基地，形成了全球化的研发、生产、营销和服务网络。微创？已上市产品约300个，覆盖心血管及结构性***病，电生理及心律管理，骨科与软组织修复，大动脉及外周血管疾病，脑血管与神经科学，内分泌管理等生命科技，外科及医疗机器人，泌尿、妇科、呼吸、消化，医美及康复医疗，与体外诊断与影像等十大业务集群。
微创？专注于自主创新并一以贯之高强度投资于研发，现已拥有专利（申请）3,500余项（国外2,000项），先后5次获得中国国家科学技术进步奖（其中一项为企业创新平台模式奖）和多个省部级科技进步奖，16个产品进入中国创新医疗器械注册绿色通道（截至2019年6月）。微创？尊崇循证医学，几乎所有核心产品与解决方案的临床应用效果（经验）都在全球主流学术杂志上得到了发表。