Posted on Oct 12th 2019

Senior Standard Compliance Engineer

中国,广东,深圳

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,广东,深圳

Full time

383519

保存职位

Job Title

Senior Standard Compliance Engineer

Job Description

In this role, you have the opportunity to

Be an integral part of the defibrillator Monitor development team and have the opportunity to work with the group of world-class, Regulatory and standard Engineers who develop products that help save lives all over the world.

You are responsible for

  • Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards
  • Review development quality reports and plans to ensure that the information required for submissions is adequate
  • Plan, generate, and coordinate regulatory submissions for product/solution licensing
  • Coordinate testing required to support regulatory submissions
  • Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and Field)
  • Maintain existing regulatory fillings/licenses, managing updates and related change control processes.
  • Assist with implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
  • Advise product design teams on regulatory strategy and requirements for specific new product introductions and product changes, and assist in maintaining regulatory compliance
  • Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registration such as CE marking, CFDA, FDA and clinical evaluations
  • Develops and facilitates regulatory submissions, for new products/solution, existing products/solutions
  • Reviews and validates marketing and labeling materials.
  • Product standard compliance testing and release reports.
  • Provide technical support in regulation and standard related field, help product register smoothly

You are a part of

  • The Senior Standard Compliance Engineer will be one member of the V&V team in our defibrillator Monitor development group within the ECR Business Innovation Unit (BIU)

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

  • The successful candidate will possess the following knowledge, skills education and experience:

  • B.S. Degree in Engineering. M.S. Degree preferred
  • 3-5 years of experience in the medical device industry
  • Must have experience with successful preparation of CFDA, CE, or FDA international documents
  • Some experience in Design Controls
  • Working knowledge of medical device regulations (21 CFR), FDA law, MDD, MDR, other global laws and regulations.
  • Experience in medical IEC/ISO standards
  • Ability to effectively communicate complex matters in simply understood terms, both verbally and in writing
  • Self-starter and innovative thinker
  • Strong ability of writing the report of issue analysis and presenting the report in team with English

In return, we offer you

  • A rewarding career, supportive atmosphere and positive work environment in which you will lead your talented, passionate team to develop life-saving medical systems.

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. Learn more by watching this video.

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.

Contact

If you forgot your password, you can click the Forgot Password  button on the Sign In screen to reset it. 

If you have any other questions regarding the recruitment process please refer to our FAQs. In case of technical difficulties with the website, please send an email to careersite@philips.com. 
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)

将此发给朋友

您是否知道可能对这一职位有兴趣的人?将链接发送给朋友吧!

你不知道的飞利浦

Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

观看视频

获得类似职位的通知

您将每周收到一次通知

* 我希望收到飞利浦工作提醒。 这是什么意思?

类似的工作

No similar jobs found