+ 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,...