Posted on Oct 12th 2019

Sr. Regulatory Engineer-International


Full time



Posted on Oct 12th 2019


Full time



Job Title

Sr. Regulatory Engineer-International

Job Description

In this role, you have the opportunity to

  • Provide appropriate global regulatory strategy and planning for new product introductions and product change; ensure timely and well organized registrations activities; Provide guidance on risk assessment, clinical evaluation and required corrective actions to meet regulatory requirements.

You are responsible for

  • Responsible for implementing regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
  • Advice product design teams on regulatory strategy and requirements for specific new products/solutions.
  • Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
  • Support development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and Product registrations.
  • Create, review and validate marketing and labeling materials while supporting projects and other key regulatory initiatives
  • Develop and facilitate regulatory submissions, for new products/solutions, existing products/solutions.

You are a part of

  • Professional Regulatory Team, with around 10+ team peers globally.

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

  • BS+ in science, engineer or regulatory affairs;
  • Minimum of 5 years’ experience in active medical device regulatory affaire role;
  • Be skillful in EU MDD/MDR, FDA and China NMPA registration is required;
  • Be familiar with global regulation requirements.
  • Proficient in English and Chinese communication including reading, writing, speaking and listening.
  • Require strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
  • High efficiency on problems solving from RA perspective;
  • Capable of handling pressures during working;
  • Willing to communicate and cooperate with cross function team members;
  • Strong ability in organizing CFT to finish tasks on time;
  • Willing to take ownership and capable of delivering fast.

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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