Posted on Oct 12th 2019

Sr Regulatory Affairs Specialist


Full time



Posted on Oct 12th 2019


Full time



Job Title

Sr Regulatory Affairs Specialist

Job Description

In this role, you have the opportunity to

  • Government relations: Familiar with the officials and understanding their requirements for timely approvals.
  • Regulations: In depth-understanding and application of SFDA and CQC regulations and the related regulatory process. 
  • Technical expertise: Knowledge of process and methods and medical product area such as product specifications, product developments / expansions and product safety.
  • Understanding of the IEC and related GB standard for good communications with the BIU and CFDA or CQC testing lab’s engineers.
  • Excellent communications skill with internal and external customers.

You are responsible for:

  • Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc.
  • Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
  • Develop and take the ownership of China CFDA submissions
  • Support Key market RA team on global registrations
  • Establish active communications with regulatory agencies in China.
  • Review and approve advertising, promotional items and labeling for regulatory compliance
  • Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
  • Communicate application progress to internal stakeholders
  • Collaborate with worldwide colleagues regarding license renewals and updates
  • Maintain regulatory files and tracking databases as required

You are part of

Regulatory Affairs team. You will base in Beijing or Shanghai, and report to the Clinical Regulatory Affairs Director/Sr. Clinical Regulatory Affairs Manager, Greater China.

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

  • BS in engineering discipline or equivalent education, experience, training.
  • At least 5 years regulatory experience in medical device industry.
  • Experience in China local manufactured or local developed products will be a plus.
  • Strong understanding of China FDA and other major international regulations
  • Be able to manage multiple tasks and perform with accuracy and a high attention to detail
  • Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
  • Proficient in English communication including reading, writing, speaking and listening.
  • In return, we offer you

    A path towards your most rewarding career. Succeeding in this role will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer ambitious health benefits, a flexible work schedule and access to local well-being focused activities. You will also enjoy a professional but fun workplace, a healthy work-life balance environment and an energetic, authentic, inventive, encouraging and dynamic team atmosphere.

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.




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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