Posted on Oct 12th 2019

Advanced Regulatory Engineer


Full time



Posted on Oct 12th 2019


Full time



Job Title

Advanced Regulatory Engineer

Job Description

In this role, you have the opportunity to

  • Ensure timely product registrations, regulatory planning for new product introductions and product changes, guidance on risk assessment, and required corrective actions to meet regulatory requirements. As well as leadership and guidance on global regulatory strategy, such as product registrations, and clinical evaluations.

You are responsible for

  • Responsible for product FDA 510(K), FDA PMA, Canada and other American countries registration, change and renew, include document preparation, submission and review feedback etc.
  • Responsible for regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance
  • Review and approve advertising, promotional items and labeling for regulatory compliance
  • Participate in and advise cross-functional product team on applicable regulations, requirements and standards;
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Collaborate with worldwide colleagues regarding license renewals and updates for other small countries.
  • Maintain regulatory files and tracking databases as required

You are a part of

•Professional Regulatory Team, with around 20+ team peers globally.

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

  • BS+ in science, engineering or clinical related discipline.
  • Minimum of 5 years’ experience in active medical device regulatory affair role.
  • Be skillful in FDA is required, MDD/MDR and NMPA will be plus. 
  • Be familiar with global regulations and have success experiences on high-class device will be plus
  • English: can read and write, good oral English communication.
  • Strong interpersonal skills to effectively compose agency submissions interface interdepartmentally and complete assignments with minimal supervision
  • High efficiency on problem shoveling from RA perspective;
  • Capable of handling pressures during working;
  • Willing to communicate and cooperate with cross function team members;

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.


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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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