长沙招聘

职位描述：
Position Summary

Working in a team of regulatory affairs professionals to ensure best practices within the assigned area of responsibility, e.g. CFDA/CE pre-market submission, approval, regulatory reporting, design controls for new product development, technical standards, collection and dissemination of intelligence, influencing the local and global regulatory environment, etc..

Key Responsibilities
1. Establish/execute a thorough submission plan for each assignment within the timeline agreed by stakeholders;
2. Work with diversified team to develop and execute regulatory strategy for complex local manufacture products and maintain existing licenses;
3. Interact with CFDA/Provincial FDA on registration/manufacturing regulation requirements and monitor changes to requirements.
4. Interact with manager as required by specific issues, milestones, or status changes.
5. Manage the regulatory review of labeling, promotional materials, technical documents, clinical protocols, and clinical reports for products that are under his/her responsibilities.
6. Ensure compliance with China regulatory requirements from pre-market perspective, including but not limited to change management, Chinese labeling requirements, etc..
7. Monitors regulatory and standards developments affecting BD product he/she is responsible for, identifies and recommends committees that BD should be part of.

Skills and abilities
1. Ability to communicate (oral/written) and interact effectively across all levels, disciplines, functions, and regions, particularly with regulators. Independently write reports/documents for distribution within division.
2. Recognizes potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas.
3. Ability to confidently deal with ambiguous issues and provide input towards suitable actions.
4. Demonstrated success in preparing, filing, and completing (including negotiations) regulatory submissions/dossiers/approvals with CFDA/CE authority.
5. Experienced in meeting with, making presentations to, and negotiating with regulators, including complex or sensitive issues.
6. Minimum 5 years working experience in medical device regulatory affairs, experience in infusion products will be a plus.
7. Interpret subjective and complex aspects of specific regulations and has general understanding of multiple sets of associated regulations.
8. Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes.
9. Independently manage and monitor multiple complex and diverse short term and long-term projects without direct supervision. Interact with manager as required by specific issues, milestones, or status changes. Maintains a “focused urgency” as required.
10. Good communication skills, able to work under pressure, delivery orientated, willing to travel.

Desirable
B.S. or B.A. degree in a technical discipline. 举报 分享

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。