Philips Regulatory Affairs Officer in Shanghai, China
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In this role, you have the opportunity to
Guide and support the R&D team to always do the right things. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
You are responsible for
Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives.
Create detailed written regulatory plans that can be used to target domestic and international shipment dates.
Develop clinical trial documentation and coordinate overall clinical trial activities.
Review and approve the human/animal experiments (not falling into the scope of clinical trials regulated by CFDA) carried out within the organization according to Philips internal policies and processes
Support stakeholders in preparing product registration submissions for CFDA registration.
Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.
You are a part of
Philips Research China and China Digital Innovation, which is under Philips Chief Technology Organization. The Regulatory Affairs Officer position was created under Q&R function and overseas the Regulatory Affairs activities. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our organization, and Q&R compliance culture.
Philips Research China and China Digital Innovation is working according to Philips Excellence Process Framework (PEPF) and in Agile principles. You will work on highly innovative. Together with your team, you will strive for continuous improvement of deliverables, your way of working and yourself.
To succeed in this role, you should have the following skills and experience
Bachelor degree required in a technical discipline.
Minimum of 5 years of experience in the medical device industry (CFDA, EU MDD, US FDA class II or class III, etc.).
Proficient knowledge of medical device regulations minimum CFDA, FDA, EU. Worldwide is desired. Must have personal experience with clinical trials and CFDA submissions.
Proficient knowledge of domestic and international standards.
Experience in supporting international registrations and/or clinical investigations.
In return, we offer you
The opportunity to play a role in achieving Philips' ambitions with digital connected products and to truly contribute to the way our innovations improve the health and well-being of our customers. You will work in close cooperation with global teams across Philips, playing a key role in driving the Q&R compliance initiatives. We invite you to be part of a challenging, innovative environment with great opportunities for personal development.
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.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .