高级法规事务规范专员_RA&C_上海
碧迪医疗器械(上海)有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械
职位信息
- 发布日期:2017-11-30
- 工作地点:上海
- 工作经验:5-7年经验
- 学历要求:本科
- 职位类别:医疗器械注册 医疗器械生产/质量管理
职位描述
职位描述:
Job Description岗位描述
Job Title职位 : Sr. Specialist or Associate Manager, Regulatory Compliance 高级专员或助理经理,法规事务合规
Department部门 : Regulatory Affairs and Compliance法规事务及规范部
Job Location工作地点 : Shanghai, P.R. China中国,上海
Report to汇报给 : Sr. Regulatory Compliance Manager 高级法规事务经理
Subordinate从属 : n/a
POSITION SUMMARY职位综述
This position is to translate post-market regulatory requirements into China working process; to play an active role to communicate with internal/external customers to ensure proper implementation of procedures in consistent with regulation.
该职位将致力于从法规合规经营的角度将后市场法规要求融入公司日常工作流程中,积极与内外部客户互动交流,确保后市场工作流程合理实施,从而符合公司流程和法规要求。
KEY RESPONSIBILITIES主要职责
1. Follow the current procedures of regulatory compliance, such as recall reporting/AER/Promotional material review and approval etc. and find opportunities to improve the process
根据现有法规合规工作流程执行日常工作,比如医疗器械召回管理流程、不良事件报告流程、文字材料审核批准流程等,并对流程进行适当改进
2. Provide proper input at country level when receiving field action notification and keep communication when necessary
收到区域行动信息时,及时提供中国的反馈并保持与总部的联系
3. Upload China AER into global vigilance and download oversea AER for submitting in China based on CFDA regulation
将中国发生的不良事件录入global vigilance系统并下载境外不良事件在中国进行上报
4. Coordinate and submit the promotional materials for SHFDA/JSFDA approval when necessary
需要时,协调并递交医疗器械文字材料,跟进上海市药监部门和江苏省药监部门进行审批流程
5. Prepare SOP training materials and provide SOP training to the relevant peers and keep training records
根据SOP制作相应的培训材料并对相关人员进行培训,保留培训记录
6. Other assignments that may have其他可能的工作安排
SKILLS AND ABILITIES技巧和能力
1. Ability to work with minimal supervision. Ability to prioritize, & evaluate deliverables. Be a proactive thinker.
具备独立工作的能力,对于所交付的工作按轻重缓急评估处理
2. Demonstrated ability to interact externally with regulators and internally with WW BD associates.
能够与公司外部监管部门及总部同事进行有效沟通和互动
3. Dependability: team work, reliable, responsible, dedicated, committed and fulfilling obligations and detailed working attitude.
可靠性:具有团队合作、值得信赖、负责、敬业、担当和细致的工作态度
4. Excellent verbal and written communication skills both in Chinese and English.
熟练的中英文沟通技巧
5. Strong interpersonal skills, ambitious and aggressive personality, can work under pressure; problem solving oriented and willing to learn
具备人际交往技巧、积极进取、能承受工作压力,以解决问题为导向工作并具有不断学习的意愿
6. Minimum three to five years of directly related experience in medical device and drug packaging product fields with regulatory compliance knowledge
至少3-5年药品、医疗器械、药包材行业等相关经历,并具有法规合规知识
DESIRABLE满足条件
B.S. or B.A. degree in a technical discipline (bioengineering, biology, microbiology, or molecular biology preferred).
技术学科领域学士学位,如生物工程、生物学、微生物学或分子生物学优先
Job Description岗位描述
Job Title职位 : Sr. Specialist or Associate Manager, Regulatory Compliance 高级专员或助理经理,法规事务合规
Department部门 : Regulatory Affairs and Compliance法规事务及规范部
Job Location工作地点 : Shanghai, P.R. China中国,上海
Report to汇报给 : Sr. Regulatory Compliance Manager 高级法规事务经理
Subordinate从属 : n/a
POSITION SUMMARY职位综述
This position is to translate post-market regulatory requirements into China working process; to play an active role to communicate with internal/external customers to ensure proper implementation of procedures in consistent with regulation.
该职位将致力于从法规合规经营的角度将后市场法规要求融入公司日常工作流程中,积极与内外部客户互动交流,确保后市场工作流程合理实施,从而符合公司流程和法规要求。
KEY RESPONSIBILITIES主要职责
1. Follow the current procedures of regulatory compliance, such as recall reporting/AER/Promotional material review and approval etc. and find opportunities to improve the process
根据现有法规合规工作流程执行日常工作,比如医疗器械召回管理流程、不良事件报告流程、文字材料审核批准流程等,并对流程进行适当改进
2. Provide proper input at country level when receiving field action notification and keep communication when necessary
收到区域行动信息时,及时提供中国的反馈并保持与总部的联系
3. Upload China AER into global vigilance and download oversea AER for submitting in China based on CFDA regulation
将中国发生的不良事件录入global vigilance系统并下载境外不良事件在中国进行上报
4. Coordinate and submit the promotional materials for SHFDA/JSFDA approval when necessary
需要时,协调并递交医疗器械文字材料,跟进上海市药监部门和江苏省药监部门进行审批流程
5. Prepare SOP training materials and provide SOP training to the relevant peers and keep training records
根据SOP制作相应的培训材料并对相关人员进行培训,保留培训记录
6. Other assignments that may have其他可能的工作安排
SKILLS AND ABILITIES技巧和能力
1. Ability to work with minimal supervision. Ability to prioritize, & evaluate deliverables. Be a proactive thinker.
具备独立工作的能力,对于所交付的工作按轻重缓急评估处理
2. Demonstrated ability to interact externally with regulators and internally with WW BD associates.
能够与公司外部监管部门及总部同事进行有效沟通和互动
3. Dependability: team work, reliable, responsible, dedicated, committed and fulfilling obligations and detailed working attitude.
可靠性:具有团队合作、值得信赖、负责、敬业、担当和细致的工作态度
4. Excellent verbal and written communication skills both in Chinese and English.
熟练的中英文沟通技巧
5. Strong interpersonal skills, ambitious and aggressive personality, can work under pressure; problem solving oriented and willing to learn
具备人际交往技巧、积极进取、能承受工作压力,以解决问题为导向工作并具有不断学习的意愿
6. Minimum three to five years of directly related experience in medical device and drug packaging product fields with regulatory compliance knowledge
至少3-5年药品、医疗器械、药包材行业等相关经历,并具有法规合规知识
DESIRABLE满足条件
B.S. or B.A. degree in a technical discipline (bioengineering, biology, microbiology, or molecular biology preferred).
技术学科领域学士学位,如生物工程、生物学、微生物学或分子生物学优先
职能类别: 医疗器械注册 医疗器械生产/质量管理
公司介绍
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for healthcare providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians’ care delivery process, enable laboratory scientists to better diagnose disease and advance researchers’ capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit ******.
关于BD
BD是一家全球化的医疗技术公司,通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者,致力于通过研发创新技术、服务和解决方案,帮助患者改善临床治疗,并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念,致力于帮助提升患者的治疗效果,为临床医护人员提供安全、高效的护理给药流程,协助实验室科学家们更有效地诊断疾病,并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构,与全球范围内的组织机构积极合作,携手应对最具挑战的全球健康问题。通过与客户的紧密协作,BD以改善治疗结果,降低医疗成本,提升诊断效率为己任,帮助加强患者和医护人员的安全并扩大医疗可及性。2017年,BD欢迎巴德及其产品加入BD大家庭。更多信息,敬请访问**********/china。
关于BD
BD是一家全球化的医疗技术公司,通过改善医学发现方法、医疗诊断效果和护理质量以引领世界健康。BD关注并支持每位一线医务工作者,致力于通过研发创新技术、服务和解决方案,帮助患者改善临床治疗,并帮助医护人员改进临床流程。BD及其65,000名全球员工秉承高度的热情和信念,致力于帮助提升患者的治疗效果,为临床医护人员提供安全、高效的护理给药流程,协助实验室科学家们更有效地诊断疾病,并提升科研人员研发新一代诊断及治疗疾病的能力。BD在几乎所有国家均设有分支机构,与全球范围内的组织机构积极合作,携手应对最具挑战的全球健康问题。通过与客户的紧密协作,BD以改善治疗结果,降低医疗成本,提升诊断效率为己任,帮助加强患者和医护人员的安全并扩大医疗可及性。2017年,BD欢迎巴德及其产品加入BD大家庭。更多信息,敬请访问**********/china。
联系方式
- Email:club@51job.com
- 公司地址:中国上海市浦东新区东育路221弄11号前滩世贸中心三期B栋12-18楼 (邮编:200040)