Philips RA Manager 

China, Jiangsu 

280035510

• Coordinate, review, and file new deviceregistration/approvals
• 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-relatedmarketingcommunications(generallyat BIU and Field)
• Maintain existing regulatory filings /Licenses, managing updates and related change control processes(generally at the BIU and field level)

You are a part of Great china Regulatory

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

• Bachelor degree above, major in medical or engineer
• More than 3 years experiences in RA area, it is better if has the experience in medical device.
• Be familiar with China CFDA and international regulations
• Good in written and spoken in English and Mandarin
• Excellent communication and interpersonal skill
• Self-starter and able to work both autonomously and as part of a team
• Good problem solving, learning, project management skill