Philips Regulatory Affairs Manager 

China, Beijing, Haidian District 

868591477

Regulatory Affairs Manager

In this role, you have the opportunity to make life better

In this role, you have the opportunity to

• Coordinate, review, and file new device registration/approvals and amendments to existing products for market access into the Peoples Republic of China. Mainly focus on localized innovation projects.
• Communicates with relevant competent authorities, agents, distributors, and local sales offices to ensure the most efficient path to application approval.
• Advise local and international teams on the most expedient route to obtaining product licenses and ensure market access strategy is aligned with local and international marketing/sales requirements. To resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales .

You are responsible for

• Participate in and advise cross-function new product/solution development teams on applications, requirements, and standards (not in the field)
• 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 andproduct/solution-related marketing communications (generally at BIU and Field)
• Review changes in existing products to determine need for new/revised submissions or document reason for no submission.
• Maintain existing regulatory filings /Licenses, managing updates and related change control processes (generally at the BIU and field level)

You are a part of

• A progressive and energetic team that contributes directly to the growth of the business.

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

• Bachelor’s degree above, major in medical or engineer
• More than 5 years experiences in RA area, it is better if has the RA experience in intravascular medical device.
• Be familiar with NMPA regulation, standard and guidance, also international regulations
• Good in written and spoken in English and Mandarin
• Excellent communication and interpersonal skill

Our hybrid working model is defined in 3 ways:

The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.