You are responsible for
1.Regulations: In depth-understanding and application of SFDA and CQC regulations and the related regulatory process.
2.Technical expertise: Knowledge of process and methods and medical product area such as product specifications, product developments / expansions and product safety. Understanding of the IEC and related GB standard for good communications with the BU and SFDA or CQC testing lab’s engineers.
? register new products according to business plan
? maintain the current licenses and register renewal products in time
? understand and keep studying all the new regulations & standards both national and international
? maintain a good business relationship with internal and external customers
? obtain company product knowledge through classroom or on the job training
To succeed in this role, you should have the following skills and experience
A degree in a scientific discipline or equivalent is desirable.
RAC Certification and/or a Masters in Biomedical Regulatory Affairs are also desirable.
Minimum of 5 years’ experience in the pharmaceutical, medical device, biotechnology and/or cosmetic (recent) industries desired.
Candidates should understand the essential framework of regulations and guidelines pertinent to their exposure areas.
Must have a basic grounding in GLP, GCP and GMP.
Must have strong interpersonal and communications skills with strong English language ability.
Must be articulate and able to communicate effectively with employees at all levels of the organization, as well as with key individuals outside the organization. These outside contacts may include Philips personnel from commercial organizations, dealers-distributors, and consultants.
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. 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.