长沙招聘

  

In this role, you have the opportunity to

  

• As an AEC (Adverse Event Coordinator), you will support MDR (Medical Device Regulation)/adverse event reporting, triage complaint records, manage high-risk complaints to CA (Competent Authority).

   

  You are responsible for

      

• Ensures timely medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation.

• Write and submit medical device reports (MDRs) and / or regulatory reporting.

• Works with a variety of diverse persons within the company such as Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements

• Provides consultation to investigator during initial check/ reportability determination

• Provides review of complaint to ensure all information needed for Reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion

• Writes MDRs/MIR reports and submit to the necessary authorities

• Monitors and improves tracking/control systems for medical device reporting

• Investigates and prepares response to address Competent Authority inquiries and provide follow-up

   

  You are a part of

                    

• The Emergency Care and Resuscitation Solutions (ECR) Post Market Surveillance Team is headquartered out of Andover, MA.  We welcome you to join Philips HealthTech as a Complaints Specialist supporting ECR. The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations.

   

  To succeed in this role, you should have the following skills and experience

      

• Bachelor’s degree required. Technical degree in scientific or healthcare-related;

• At least 3 years of Quality and/or Regulatory experience is required, experience in Post-market Surveillance is an advantage, Experience with Complaint Handling Software, Databases, and Microsoft Office is preferred, Previous experience in medical device and or applicable product is preferred;

• Excellent Chinese and English communication skills are required (verbal, written, and presentation)

• Medical device and or other regulated industry (Pharma, IVD) preferred

• Basic knowledge of ISO13485

• Local post market surveillance regulation (21CFR, MDD, EU-MDR and other applicable market regulation) and ISO14971;

• Product knowledge is preferred.

• Ability to effectively manage time.

• Ability to handle multiple task assignments.

   

  In return, we offer you

  At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2025.  This position offers the opportunity to influence regulatory compliance worldwide and directly improve the customer and patient experience.  We offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

   

  Why should you join Philips?

  Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

   

                                

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

  

 

  

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

  

 

  As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 

荷兰皇家飞利浦公司是一家领先的健康科技公司，致力于在从健康生活方式、疾病预防、到诊断、治疗和家庭护理的整个“健康关护全程”，凭借先进的技术、丰富的临床经验和深刻的消费者洞察，不断推出整合的创新解决方案，助力健康医疗系统实现四重目标——提高大众健康水平、提高医护人员满意度、改善患者体验，并降低关护成本。飞利浦的愿景是通过有意义的创新，令世界更健康、更可持续的发展，到2030年每年改善25亿人的生活。

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        在飞利浦，每一个人，都至关重要。这是我们始终坚持的信念。在飞利浦，你将用数字化驱动有意义的创新，积极影响自己与数十亿人的生活，践行改善人类生活的使命。我们全心营造多元包容的工作环境，平等互助的工作氛围，让你的独特之处得到充分尊重和欣赏，鼓励你释放真我，以梦为马，不负韶华。本着 “立足中国，辐射全球” 的理念，我们通过布局广泛的业务线，为你带来广阔的平台、丰富的学习资源、多样的内部发展机会，助你成为具备全球化视野和本土深度的一专多能复合型稀缺人才。

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我们深信每一个你都卓尔不凡, 更期待与志同道合的你笃行致远。