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
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.
- Follow the current procedures of regulatory compliance, such as recall reporting/AER (Adverse event report) and find opportunities to improve the process
- Provide proper input at country level when receiving field action notification and keep communication when necessary
- Upload China AER into global vigilance and download oversea AER for submitting in China based on CFDA regulation
- Prepare SOP training materials and provide SOP training to the relevant peers and keep training records
- Other assignments that may have其他可能的工作安排
SKILLS AND ABILITIES技巧和能力
- Ability to work with minimal supervision. Ability to prioritize, & evaluate deliverables. Be a proactive thinker.
- Demonstrated ability to interact externally with regulators and internally with WW BD associates.
- Dependability: team work, reliable, responsible, dedicated, committed and fulfilling obligations and detailed working attitude.
- Excellent verbal and written communication skills both in Chinese and English.
- Strong interpersonal skills, ambitious and aggressive personality, can work under pressure; problem solving oriented and willing to learn
- Minimum three to five years of directly related experience in medical device and drug packaging product fields with regulatory compliance knowledge
B.S. or B.A. degree in a technical discipline (bioengineering, biology, microbiology, or molecular biology preferred).
Primary Work Location
CHN Shanghai - HQ
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.