Associated RA manager Suzhou

Job Title

Job Description

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 and product/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 Great China RA Team

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

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

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

About Philips

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.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.