上海招聘

Talent@Boehringer Ingelheim

About Corporate Functions

Corporate functions staff are the backbone of the company: talented, conscientious professionals who think outside the box and get things done. We set Boehringer Ingelheim's strategic compass to sustainable, reliable, innovative and customer-oriented. Internally, we ensure we have the employees' company needs covered so they can develop and grow here successfully. We also offer intelligent solutions and systems, overlook processes, investments and budgets, provide guidance to our businesses, and communicate to our internal and external stakeholders. We are proud of being a strategic partner to our business functions.

Job Responsibilities

To build / introduce Medical Device QMS to guide full product life cycle from design to post market and make sure compliance and effectiveness at the same time.  

-Deputy Management Representative: in the late of the project, he/she shall be able to act as deputy management representative for medical device and combination products.

-Develop and execute quality design and quality assurance strategy for new product development, changes and improvements.

-Direct the development of systems, practices and processes to ensure effective ongoing review of product design or other operational and manufacturing changes.

-Quality Assurance & Compliance

-Coordinate and conduct all 3rd party supplier data into the Quality system management reviews.

-Responsible for strategic leadership of Quality Management System (QMS).

-Coordinate and conduct all 3rd party supplier data into the Quality system management reviews. Coordinates and provides various subject matter expertise in preparation for MOH and Notified Body inspections and ensures inspectional responses are finished in a timely manner. Host regulatory/ notified body inspections as appropriate.

-Set, maintain and train cross-functional teams on regulatory policies and quality standards for all quality systems and ensure compliance with applicable regulations worldwide.

-Facilitate management review of QMS to monitor performance and create/support process enhancement initiatives to drive continuous improvement.

-Drive execution of QMS processes through programs, policies and functions that support corporate and product quality.

-Provide regulatory oversight for compliant product promotion.

-Oversee preparation and filing of all regulatory documents with the requirement of NMPA and international regulatory agencies, within applicable regulations and guidelines.

-Rich type II medical device registration experience. Good communication skills, especially for experience of NMPA’s consultation meeting.

-Develop and maintain external relationships with relevant opinion leaders and regulatory officials.

-Collaborate cross-functionally with internal departments on strategy development, risk assessments and implementation of quality principles and regulatory requirements.

 

Qualifications
-Degree:Bachelor Degree is minimum required.

-Over 6 years of QA/QC/RA experience in medical device product environment. 
-Sound technical skills including working knowledge of medical device registration, regulatory intelligence, regulatory submission support, quality assurance, and analytical testing technologies.
-Experience with and ability to manage and influence regulatory agency personnel at all levels, both in field compliance and agency centers.
-Experience in i) digital product development using agile methods (such as Scrum, Kanban, Lean Startup, etc.) and ii) customer centric environments/products, where continuous user research was performed is strongly preferred.
-Excellent judgment and decision-making capability in the technical and compliance arenas.
-Excellent analytical, interpersonal and verbal/written communication skills, with both internal constituencies and external regulatory stakeholders.
-Strong analytical and information retrieval skills
-Integrity, judgment, and the ability to hold one’s ground under pressure.
-Ability to work in a multinational, multicultural and highly matrix environment.
-Team player with strong customer orientation.
-Knowledge and experience in pharmaceutical and medical device product documentation procedures with proven ability or project experience in developing systems and business processes to improve overall efficiency and productivity.
-Ability to influence individuals that are outside the span of direct control (i.e., influence without authority).
-Must have excellent Organizational Skills. Must be detail and quality oriented.
-Proficient in computer skills and hands on experience in different computer software such as database management, spreadsheets, project management, presentations word processing flowcharting and/or any other similar type of programming. Project management experience in Medical Device clinical development in China is a must.
-Language skills & proficiency:Excellent Chinese and English skills, both written and spoken.

关于勃林格殷格翰
加入勃林格殷格翰，与我们一起携手并肩，共创未来。我们深信每一位员工的成长都将铸就公司的发展，每一位员工的努力也都将成就公司的美好明天。130余年来，研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一，持续致力于人用药品、动物保健和生物制药合同生产三大业务领域，力争为人类和动物带来更多健康。加入勃林格殷格翰，将是您实现“创新展现价值”的绝佳机会！在工作中，您将通过与内外部伙伴的通力合作，站在知识迭代的最前沿；科研过程中，您将不断探索新型科学发现，切实提高全人类的生活质量；与此同时，您也将助力公司成为未来行业当之无愧的领导者。

我们的业务正处在持续高速发展之中，是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰，共同携手向前，成为实现2025愿景的一份子。

作为业内的领导企业，热情、创新和独立是驱动我们不懈前行的动力，我们为每一位努力热忱、恪尽职守的员工提供成长机会，实现其个人价值。作为连续八年通过“中国杰出雇主”认证的企业，我们通过提供高质量的职业发展规划、参与或领导国际项目的机会，为每一位员工的成功之路夯实基础。
 让我们彼此成就，引领未来！

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行为准则
-责任心：即使情况不明朗，我们总是在自己的决策和行为中展现主人翁精神
-敏锐度：面对内外部变化时，我们以开放的心态快速应对
-内部企业家精神：我们与客户携手构筑创新理念，以应对瞬息万变的市场

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