天津招聘

职位描述：
Key Responsibilities:

SME (subject matter expert) of medical device (md)/in vitro diagnostic (IVD) , especially IVD antibodies, lead a group to provide regulatory support to company IFE science business. include but not limited
work with global team and/or local agency to prepare regulatory submission documents for MD/IVD products, implement md/IVD products registration/renew/supplementary application. manage the registration project progress, make sure to meet the time line. responsible for post-market regulatory compliance
monitor MD/IVD related regulation changes, evaluate the impact, provide regulatory guidance in risk assessment and recommendations to mitigate potential risk
actively communicate with business, marketing team, provide regulatory consultancy and regulatory strategy for MD/IVD project
work as effective interface between company and authority/industry association
responsible for company life science animal by-products (ABP), biologics special products and hard wares importation regulatory compliance
coordinate related function departments to drive, manage the ABP and biologics products’ compliance importation
lead a group to prepare documents for import permit application, submit and follow up application process with local authority, make sure get import permit approval per plan
keep good connection with local authorities (AQSIQ, local CIQ), monitor relevant regulation changes, timely inform internal stakeholders about regulations with impact to business
provide regulatory consultancy and strategy for new biological material importation project
responsible for coordinate with global team to ensure 3c compliance or out of scope license registration
responsible for coordinate with global team to ensure energy label compliance or out of scope license registration


Key Requirements:

technical degree required, biopharmaceutical, bioscience related science and/or engineering discipline > 6 years experience
fluent in Chinese native & English (verbal and written) is required
experience of minimum six years in MD/IVD regulatory affairs, extensive knowledge of china regulations in MD/IVD, especially familiar with IVD antibodies
familiar with regulations of ABP and biological material importation is a plus
experience working in a global, matrix environment
excellent interpersonal, presentation, listening and communication skills
strong organizational and time management skills
ability to manage multiple priorities and deliver accurate outcomes
ability to indirectly influence other organizations and cultures
ability to work in multi-cultural teams and strong people leadership 举报 分享

华德士中国

华德士于2008年进入中国市场，目前在上海、苏州及华南地区设立有分公司。我们凭借专业素养和丰富经验为各大公司招聘***双语人才，并于最近被评选为***国际人才招聘顾问机构。

我们的顾问都有相关行业的从业经验，因此能更深刻地理解您的需求。我们主要为以下领域招聘中高级专业人才：会计与财务、银行与金融服务、工程与运营、高层管理、人力资源、信息技术与转型、市场营销、采购与供应链等领域。