Philips Associated RA manager 

China, Jiangsu 

390324636

Associated RA manager

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-relatedmarketing 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)

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 Q&R area, it is better if has the RA experience in medical device.

• Be familiar with China NMPA 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

How we work together

Indicate if this role is an office/field/onsite role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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