In this role, you have the opportunity to
Participate in and advise cross-functional team on the applicable requirements for remediation per EUMDR regulation;
Review the existing and/or improved protocols and reports to ensure the information required for EUMDR tech file is adequate;
Review and approve product labeling and marketing promotional materials for the responsible products；
Plan, generate and coordinate the EUMDR tech file, FDA 510(k) and other submission dossier for a timely submission;
Maintain and update the regulatory licenses per the change control processes.
You are responsible for
This position is responsible for managing the global regulatory submission for the responsible products, including but not limited to EU, US, Canada, China and all other targeted markets.
Participate in the cross-functional team to advise and drive the remediation per the EUMDR gap assessment.
Review and approve the functional deliverables to work out the EUMDR tech file on schedule.
Participate in CPE team for the change assessment per the applicable change control procedure, and contribute the regulatory assessment.
Participate in NPI project to provide the regulatory guidance towards the launch of new product.
Participate Standard Review Board to contribute the standard change/update for the responsible product portfolio.
Collaborate with R&D team to coordinate testing required to support regulatory submissions.
Review and approve the product labeling and marketing promotional materials for the responsible products.
Lead the submission dossier for the change notification in EU, US, Canada, and China in order for a timely clearance.
Draft and maintain the global submission file to support the global initiative for the new submission and/or license amendment.
Support the site audit for the responsible products, including NB surveillance audit, FDA inspection, MDSAP audit, NMPA GMP audit, and all kinds of unannounced audits etc.
You are a part of
GSC China, Q&R R&C MA
To succeed in this role, you should have the following skills and experience
Fluent in both Chinese and English language.
Bachelor’s degree preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
Minimum of 6-8 years of experience in the medical device industry (Preferably in EU MDD/MDR, US FDA class II, China CFDA Class II & Class III etc.).
Strong background in design controls in medical device industry.
Proficient knowledge of medical device regulations (21CFR), MDD/MDR, China CFDA and other global laws, regulations and standards.
Experience in supporting international registrations and/or clinical investigations.
Proficient computer skills in Microsoft Office.
May require 20% travel annually.
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
• A professional but fun workplace, a healthy work-life balance environment;
• An energetic, genuine, inventive, supportive and dynamic team atmosphere;
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 https://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 at https://youtu.be/ocnMFp1JBuM .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at https://www.careers.philips.com/professional/global/en/workingatphilips on our career website, where you can read stories from our employee blog at https://www.careers.philips.com/global/en/blog-unexpected . Once there,you can also learn about our recruitment process at https://www.careers.philips.com/global/en/recruitmentprocess , or find answers to some of the frequently asked questions at https://www.careers.philips.com/global/en/faq .