Job Description
+ Leveraging regulatory affairs expertise in the medical device industry to support clients with Quality Assurance and Regulatory compliance requests
+ Preparing/reviewing local MFDS regulatory submissions and compiling technical documentation in line with applicable regulations
+ Identifying compliance gaps and providing guidance for resolution
+ Conducting research on regulatory requirements for the Korea markets and preparing peer-reviewed reports
+ Supporting implementation and maintenance of Quality Management Systems (e.g., KGMP, ISO 13485, QSR, MDSAP)
+ Performing internal and supplier audits for manufacturers, distributors, and vendors
+ Reviewing regulatory documentation, preparing premarket submissions, and supporting deficiency responses from regulatory authorities
+ Conducting literature reviews and preparing Clinical supporting documentation
+ Advising on labeling, marketing materials,...
+ Preparing/reviewing local MFDS regulatory submissions and compiling technical documentation in line with applicable regulations
+ Identifying compliance gaps and providing guidance for resolution
+ Conducting research on regulatory requirements for the Korea markets and preparing peer-reviewed reports
+ Supporting implementation and maintenance of Quality Management Systems (e.g., KGMP, ISO 13485, QSR, MDSAP)
+ Performing internal and supplier audits for manufacturers, distributors, and vendors
+ Reviewing regulatory documentation, preparing premarket submissions, and supporting deficiency responses from regulatory authorities
+ Conducting literature reviews and preparing Clinical supporting documentation
+ Advising on labeling, marketing materials,...