In this role, you have the opportunity to

• Provide regulatory guidance to the cross functional team;
• Lead regulatory strategy on the assigned projects.

You are responsible for
 Assisting with implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy
 Advises product design teams on regulatory strategy and requirements for specific new product /solutions
 Responsible for product registration/approvals;Develop and take the ownership of China NMPA submission
 Responsible for regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance
 Develops and facilitates regulatory submission for new products/solution, existing products/solutions
 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
 Maintain regulatory files and tracking databases as required

You are a part of

• Professional Regulatory Team, with around 4 team peers.

To succeed in this role, you should have the following skills and experience
 BS in science ,engineer or regulatory affairs;
 Minimum 5 years’ experience in active medical device industry;
 Be very familiar with on EU MDD/MDR, FDA 21 CFR, and China NMPA requirements (preferably in Class III active device experiences in EU, NMPA and FDA);
 Be familiar with global regulations and have success experiences on high-class device, such as but not limited to CMDR, JPA, ANVISA, TGA, KFDA.
 Experience in China local manufactured or local developed products will be a plus
 Proficient in English communication including reading, writing, speaking and listening.
 Requires 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 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.