青岛招聘

Lead a team of regulatory affairs professionals to ensure establishment of best practices within the assigned area of responsibilities, inclusive but not limited to NMPA pre and post market regulatory activities & NHC filing of ASP China products, regulatory intelligence as well as to set up the strategy from regulatory perspective to support business growth:
1. Leads a team to set up short-term and long-term regulatory strategy and efficiently implements the strategies to ensure successful market access of new products, transitioning/maintaining/updating the existing licenses/approvals, and regulatory compliance;
2. Establishes and implements local procedures to ensure regulatory submissions, approvals are the most efficient per regulation requirements and international guidance where applicable;
3. Develop, initiate, and revise procedures to regulatory affairs to ensure compliance to the medical device and disinfectant products and company policy;
4. Ensure the medical device GSP filing being efficient and successful and regulatory compliance (promotions material, graphics, complaints, AEs, field actions, health authority audit, etc.);
5. Support the team to collect, monitor, analyze and interpret product relevant regulations, industrial standards, national standards professionally;
6. Provides strong support to and communication with internal stakeholders to support business growth;
7. Provide strong support to audit, post market surveillance activities from regulatory perspective;
8. Monitor new and revised regulatory requirements, proactively influences local authorities (inclusive of but not limited to NMPA and NHC) on relevant regulations, guidance, and standards, timely analyze and communicate new/changes of the requirements;

Required Competency:
1. Bachelor degree in bioscience or a comparable combination of education and experiences;
2. >8 years regulatory experiences in MNC medical device company;
3. Demonstrates profound knowledge and expertise in medical device regulations in China;
4. Expertly manages regulatory activities across product lifecycle;
5. Proactively and accurately assesses and interprets regulatory requirements and impacts and timely feedback to relative counterparts;
6. Obtains faster approval with effective assessments and robust proposals;
7. Experiences in complex regulatory activities, effectively and efficiently facilitates the discussions with regulatory authorities;
8. Promotes regulatory function by sharing regulatory expertise;
9. Collect the regulatory intelligence and feedback to all counterparts timely;
10. Stakeholder management;
11. Incorporate local requirements, business needs objectives and priorities in development of local regulatory strategies and ASP positions;
12. Experience with/participation in Regulatory Authority Inspection/Audit
13. Good communication skill, fluent in English
14. Strong Leadership

ASP是全球领先创新灭菌和消毒解决方案供应商，总部位于美国加利福尼亚州欧文市，在世界各地设有多个办事处。 ASP支持医疗机构保护患者免受医源性感染的影响，其解决方案包括提供设备、耗材和软件，用于可重复使用手术器械的低温终端灭菌和高水平消毒。加入我们，共同为患者及其家人、医疗工作者以及社区生活创造安心的环境。