Posted on Oct 12th 2019

Senior Standard Compliance Engineer


Full time



Posted on Oct 12th 2019


Full time



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.


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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.




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