广州招聘

职位描述：
CFDA Project Manager
The CFDA Project Manager is in charge of leading and coordinating all the stakeholders (and the activities performed by these stakeholders) involved in obtaining the CFDA license of IBA PT Equipment in China.

These stakeholders are the following:
? Local regulatory authorities involved in granting the medical equipment operating license(s) in China like CFDA, CMDA, etc
? Notify Body to these local regulatory authorities (BIMT) as well as any consulting firm involved in the process of providing information and expertise
? Internal IBA departments contributing to the process of obtaining the license
o Product / Marketing
o R&D
o QRS (Quality, Regulatory and Safety)
o PT-Services
？ Resources coordination (like flyting engineers)
？ Coordination with the local PT Sites for the purpose of organizing testing
？ Coordination with the project managers of the impacted projects
？ PCO to organize the logistics
o Manufacturing & Supply Chain (testing material/equipment)
o Financial controlling for the financial follow up of the project
? External subcontractors like testing labs
? Final customer to coordinate their contribution to the process
? Any other stakeholder involved in the process
The overall objective of the CFDA Project Manager is setting up a plan to obtaining the CFDA approval of the IBA PT Equipment and ensuring that all the activities of that plan are scheduled and performed within quality/time/budget to achieve that purpose.

To achieve these goals, the CFDA Project Manager will
? Organize and coordinate the necessary resources (material and labour / internal and external) according to the project goal, in compliance with the required level of quality and performance.
? Analyze and manage risk (technical, financial, regulatory, quality, safety, feasibility, financial, etc)
? Be the main internal and external point of contact for the project execution with a customer satisfaction mind-set
? Generate and communicate progress reports, KPI as well as any report and/or action plan necessary for decision-making.
? Identify development issues early and seek continuous improvement

To be successful in the CFDA Project Manager role, the ideal candidate must meet the following requirements:
? Proficient in English (written & spoken).
? Understanding Chinese would be a significant plus
? Have a strong project management mindset, proven leadership skills and experience managing a team of internal and external stakeholders.
? Technical expertise of the PT equipment as well as regulatory interest and willingness to broaden knowledge is an added value
? Be able to motivate, support and empower people
? Present a powerful and positive professional image to the team
? Constantly work with a solution focused approach, striving to determine what are the best actions needed to complete the team's assignments
? Be rigorous while flexible and open to different ideas and views
? Strong communication skills based on active listening
? Use diplomacy in negotiating in order to reach ideal agreements with involved stakeholdersque

The CFDA Project Manager will report to the APAC PT Project Director (PT-Services). 举报 分享

IBA China 亿比亚（北京）粒子加速器技术有限公司

IBA 历史 / 领衔技术前沿 20 年

1947 年： Louvain-la-neuve 天主教大学（ UCL ）的粒子回旋加速器研究中心生产了粒子回旋加速器。

1986 年： IBA 公司从 UCL 的粒子回旋加速器研究中心剥离出来，正式成立。公司的注册办公地点位于比利时的 Louvain-la-Neuve 。公司定位于粒子加速器技术领域的专业技能来满足医药和工业领域不断增长的需求。IBA 最初从事医学图象处理，后来很快意识到了多元化的必要。因此，公司将注意力转移到放射性治疗，并开发了粒子回旋加速器，它在治疗各种癌症方面具有前所未有的精确度和效率。

1992 年： IBA 将业务拓展到消毒和电离等工业领域，向市场推出了 Rhodotron 。这是一种基于 “ 法国核能委员会 ” 提出的专利概念的粒子加速器。

1998 年 6 月： IBA 在 Brussels 证券市场上市并融资，这使得 IBA 能够通过内部增长和对其他公司的收购加速发展，所收购的公司的技术和服务加强或补充了 IBA 的核心竞争力。

IBA在中国

2004年：IBA将亚太地区总部设在中国北京。我们开始作为一个年轻有活力的公司投入运营，专注于为亚太地区的顾客提供优质产品和服务。

IBA中国的业务还拓展到遍布中国大陆、中国台湾、韩国、印度、日本、新加坡和马来西亚以及不久的将来即将覆盖的更多地区。

在IBA中国的每一位员工都要经过人力资源部门针对我们核心价值观，即关爱、分享、创新和公平，我们的使命：“保护、改善和拯救生命”以及我们的产品的各种培训。通过培训保证IBA中国的每一位员工都向一个共同的目标努力，如同癌症抗争。