Regulatory Affairs Manager

Qualifications:

degree or above in a relevant discipline required

years of industrial experience in IVD or medical device FDA registration

in Chinese preferred

Tasks:

and support new product 510k Submissions

and support International Device Licensing and Registrations

product development teams with new product submission requirements

guidance on worldwide regulatory requirements for medical devices and external government product audits by FDA and other inspection agencies as needed

and support the implementation of clinical research projects

and support clinical sites management through all phases of the clinical trial

to clinical sites during the qualification phase and as needed to ensure sites are in compliance and regulatory and study requirements are being fulfilled

that documentation from clinical trial sites meets FDA/GCP/GDP requirements