RA Manager

In this role, you have the opportunity to

Be a part of team to build a high growth business that will help improve the lives of millions of men, while advancing Philips digital transformation journey as a global leader in Health Technology.

You are responsible for

• Lead the regulatory tasks/assignments to support biz growth.
• Actively participate as team member on all assigned new products.
• Create regulatory plan using Regulatory Intelligence and in collaboration with region/country RA to ensure all requirements are met for country submissions.
• Create and file submissions; Communicate with authorities regarding these submissions.
• Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products.
• Review changes in existing products to determine need for new/revised submissions or document reason for no submission.
• Facilitate testing and inspection from CFDA, ETL, CSA, TUV and other regulatory agencies.

You are a part of

A progressive and energetic team that contributes directly to the growth of the business. You have a direct reporting line to the China CT/AMI BU RA manager

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

• Bachelorâs Degree & minimum of 3 yearsâ experience in the medical device industry or with medical product regulatory agencies. Experience of Class III active medical device registration with NMPA is strongly preferred.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals.
• Proven application of analytical skills in a regulatory environment.
• Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English.
• Demonstrated knowledge & experience conducting scientific, regulatory or business research.
• Strong problem solving and negotiation skills.
• Ability to work well independently & in a team setting.
• Knowledge of Quality Management Systems (QMS).
• Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.

In return, we offer you

We offer experiences and opportunities that add many unexpected and enriching moments to our employeesâ lives. Especially when the innovative health technologies and solutions they help develop benefit their own friends and family.

Why should you join Philips?

Working at Philips is more than a job. Itâs a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what itâs like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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 youâre 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.