Philips RA Operations Specialist in Suzhou, China
In this role, you have the opportunity to
Be a part of team of 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
Actively participate as a team member on all assigned projects supporting Philips Ultrasound devices;
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
You are a part of Philips Ultrasound Regulatory Affairs Organization with a global footprint. You will report to China Philips Ultrasound Regulatory Affairs Leader. The Regulatory Affairs team is multicultural and are enthusiastic professionals that work as a team to ensure regulatory compliance.
To succeed in this role, you should have the following skills and experience
Bachelor’s Degree & minimum of 3 years’ experience in the medical device industry or with medical product regulatory agencies.
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 employees’ 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. It’s 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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
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