北京招聘

职位描述：
Job Title: Quality Control & Regulatory Affair Manager
Reports to: Operation Manager

Essential Functions

Maintain and enhance related procedures to fit with applicable government regulations and third party requirements.
Coordinate CFDA regulatory inspections, raises corresponding corrective actions and implemented
Monitor the product changes in pipeline, regulation trend and new CFDA related standards, and communicate with concerned department and corporate for change analysis and registration strategy discussion
Cooperate with HQ for all regulatory system related issues
Well organize registration record and archive according to RA SOP and department procedures;
Quality control of all products and procedures (Medical device and consumer products)
Adverse event reporting and Recall issue handling.
Medical device, trademark registration information management.
External standards and regulations collection and management (ISO, CFDA, GB).
Insurance code, pricing application, legal affairs & contracts supports (TBD)

Job Requirements and Qualifications

Bachelor Degree or above, with a minimum of 6 years of relevant working experience in Regulatory Control or Quality fields.
Competencies Familiar with the requirements of relevant National or International Medical Device Regulations, Knowledgeable in CE, ISO-13485 is welcomed.
Fluent in English (oral and reading and writing).
Good communication and inter-personal skills, Proactive working attitude.
Familiar with MS office software, documentation skill is preferred.
Experience in Medical Device is a must.. 举报 分享

美德乐于1961年由Olle Larsson先生在瑞士成立，通过科学研究和产品创新，美德乐从一个瑞士家族企业发展成了全球先进的吸乳器和医疗负压解决方案制造商。我们致力于通过基于科研母乳喂养医疗负压解决方案来提升人类的健康和幸福生活。美德乐提供全套母乳喂养解决方案，产品覆盖高端吸乳器、孕产内衣、乳房护理、母乳存储、清洁消毒和知识服务六大领域。

To us, caring is natural. It is life giving – and life changing.
于我们，关爱是我们自然而然和与生俱来的本能。它给予人类生命力 - 与时俱进又生生不息。
That’s why caring has always guided everything we do at Medela. As a family company, you could even say it’s in our DNA.
这种关爱持续引领着美德乐前进。作为一个家族企业，这也早已深深融入我们的DNA之中。
Over the last 60 years, our company has been devoted to the science of making the most delicate form of care simple, intuitive and effective. For those receiving care as well as those providing it.
在60多年的科研里，我们让这种关爱变得简单直观又行之有效。我们授人以鱼更授人以渔。
Our team is passionate about our commitment to Swiss quality and service, because we know that is how trust is earned.
我们承诺瑞士品质和服务，对此充满热忱，因为我们知晓这是赢得消费者信任的关键。
We understand the needs of moms and babies, patients and the professionals who dedicate themselves to their care.
我们悉心倾听了解每一位妈妈、宝宝、患者和医护专业人士的需求。
By advancing research and gaining deep insight of natural behavior, we develop forward- thinking innovation to nurture life for generations.
得益于长期科研和对消费者行为的深入洞察，我们不断进行前瞻性的创新，致力于造福下一代。
We care about the world around us and commit ourselves to advocacy, sustainability and you, to build a legacy that we all can be proud of.
我们关爱我们周围的世界，并以行动来实现我们的承诺 —— 倡导母乳喂养、可持续性发展、关爱个体，以打造我们引以为豪的品牌传承。
Across the difference stages of life, our products go beyond form and function. They heal, nurture health and build bonds. Building better outcomes through equal parts physics, compassion, engineering, and humanity.
在不同的人生阶段，我们的产品超越本身的形式与性能，它们帮助治愈身体、培育健康和建立亲密联结。结合物理学、工程学、人文博爱和倾心聆听来实现更好的成果。
Because we realized early on that the first step in caring is understanding.
因为我们知道，悉心理解、感同身受，是关爱的***步。
And we’ve been caring for moms and babies, patients and healthcare professionals for so long, we’ve turned it into a science.
长久以来，美德乐悉心关爱每一位妈妈、宝宝、患者和医护专业人士。
我们用爱启迪科技，用科技成就爱。