注册经理

In this role, you have the opportunity to
• Coor******** rev******** an******** new device registration/approvalsan******** to existing products for market access into the PeoplesRepublic of China. Communicates with relevant competent author********agents, distributors an******** sales offices to ensure the mostefficient path to application approval.
• Advise local an******** teams on the most expedient route to obtainingproduct l******** an******** market access strategy is aligne********local an******** marketing/sales requirements.
• To resolve any conflicts of strategy with marketing/sales strategiesan******** the regulatory impact of such strategy on license approval timescales.


You are responsible for
• Advise internal stakeholders (market******** manufactur********R&D, etc.) regarding curren******** gu******** regulat********Agency/industry ******** etc.
• Create detaile******** regulatory plans that can be use******** targetdomestic an******** shipment dates.
• Develop an******** the ownership of China CFDA submissions
• Support Key market RA team on global registrations
• Establish active communications with regulatory agencies in China.
• Review an******** a******** promotional items an******** forregulatory compliance
• Identify potential regulatory approvals risks base******** changes inregulat******** standards country specific issues or other uniquecharacteristics of the project.
• Communicate application progress to internal stakeholders
• Collaborate with worldwide colleagues regarding license renewals an********
• Maintain regulatory files an******** databases as required

You are a part of

Great china Q&R team
To succee******** this role, you shoul******** the following skills an********
• BS in engineering discipline or equivalent e******** exper******** training.
• At least 5 years regulatory experience in medical device industry.
• Experience in China local manufacture******** local develope********will be a plus.
• Strong understanding of China FDA an******** major international regulations
• Be able to manage multiple tasks an******** with accuracy an********high attention to detail
• Requires strong wr******** oral an******** skills to be able toeffectively compose agency subm******** interface interdepartmentallyan******** assignments with minimal supervision.
• Proficient in English communication including rea******** wr********speaking an********.



In return, we offer you
A path towards your most rewarding career. Philips is growing itsmarketing capability enterprise wide. Succeeding in thismarket-base******** in a complex environment will open many doors foryour long term career, in other areas in Philips or otherwise. We alsobelieve that we are at our best as a company when you are at yours as aperson. Thus, we offer competitive health benef******** a flexible workschedule an******** to local well-being focuse********.

• A professional but fun workplace, A healthy work-life balance envi