BD (Becton, Dickinson and Company) 注册专员-法规事务部-北京 in Beijing, China
Job Description Summary
Reporting to the Medical Device Regulatory Manager BD China, works with a team of regulatory affairs professionals to ensure establishes best practices within the assigned area of responsibility. E.g. CFDA Pre-market approval submission & regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the global regulatory environment, etc.
Prepare pre-market submissions (including type testing, registration files etc.) and obtain approval of premarket product registration timely. Acts as the Regulatory partner for the BU he/she is responsible for.… Interact with CFDA on registration requirements and monitor changes to requirements. Independently manages and provide regulatory guidance to multiple long-term projects without direct supervision. Manages a single discipline within the unit on a project or short-term basis. Interacts with manager as required by specific issues, milestones, or status changes. Represents BD externally in long term project in specific fields. Accepts accountability for RA within BD on multi disciplinary platforms. Manages the regulatory review of labels, labeling, promotional materials, clinical protocols, and clinical reports for products that are under his/her responsibilities. Ensures compliance with China regulatory requirements, including but not limited to change management, Chinese labeling requirements, etc. Monitors regulatory and Standards developments affecting BD product he/she is responsible for, Identifies and recommends committees that BD should be part of.
Primary Work Location
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.