Job Title
Regulatory Affairs Engineer
Job Description
In this role, you have the opportunity to

Know customer needs and regulatory requirement of medical device;
Familiar with advanced product development process and QMS;
Be expert of product certification;
Handle the regulatory affairs in Shenzhen facility, ensure NMPA regulatory compliance.
You are responsible for

Register SRC Shenzhen products to NMPA, responsible for registration strategy and process design, registration file preparation, registration testing, clinical evaluation, and guide preparation of NMPA registration QS audit. Analyze NMPA regulatory and standard requirement of product, and input to project process. Analyze, communicate and figure out the question in registration testing and technical review. Analyze effect of regulatory and standard change, and propose solution. Support NMPA GMP registration/routine/fly inspection, ISO 13485/QSR 820/MDSAP audit. Support US/CE/International registration of SRC Shenzhen products. Communicate with China Marketing for registration/trading requirement. Handle Post Market Service (Surveillance) needs. Maintain Good Relationship with NMPA corresponding officials.

You are a part of

A professional and energetic global Regulatory Affairs team, with 4 team members at Shenzhen site.

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

Education: Bachelor degree or equivalence in Pharma, Science, Engineering or related areas. Experience: 2 years or above experience in NMPA registration is required, familiar with ISO 13485, US FDA Competencies and Skills:

Technique analysis and NMPA GMP understanding;
Proficiency in file preparation;
Good communication skills;
Understanding and proficiency for NMPA and governmental work flow
Good at reading and written English.
In return, we offer you

Experience working in an excellent manufacturing site and promising career 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. 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 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.

Contact
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