Senior Quality & Regulatory Affairs Consultant

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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, and website content from a regulatory perspective
Adhering to Underwriters Laboratories’ Code of Conduct and security practices

Bachelor’s degree in a relevant scientific discipline (e.g., Biomedical Engineering, Quality Engineering, Microbiology, Chemistry)
Minimum 5 years of experience in Quality Assurance and Regulatory Affairs, ideally with some leadership exposure
Strong understanding of global medical device regulations, particularly MFDS, KGMP, MDSAP countries, and/or the US
Experience in preparing and reviewing technical documentation
Familiarity with risk management processes (ISO 14971)
Client-facing experience with strong interpersonal skills
Fluency in English

OTHER DESIRED COMPETENCY AND QUALIFICATIONS: