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BD (Becton, Dickinson and Company) (高级)法规合规专员_QA&C_上海 in Shanghai, China

Job Description Summary

Job Title职位 : (Sr.) Specialist, Regulatory Compliance (高级)专员,法规合规

Department部门 : QA & C

Job Location工作地点 : Shanghai, P.R. China中国,上海

Report to汇报给 : Associate QA Director 质量副总监

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 (Adverse event report) 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,并对流程进行适当改进

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. 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

  1. Excellent verbal and written communication skills both in Chinese and English.

熟练的中英文沟通技巧

  1. 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

  1. Minimum three to five years of directly related experience in medical device and drug packaging product fields with regulatory compliance knowledge

至少2-3年药品、医疗器械等相关经历,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

Primary Work Location

CHN Shanghai - HQ

Additional Locations

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

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