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Philips Associate Regulatory Affaris Manager in Shanghai, China

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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 .

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