Senior Quality & Regulatory Affairs Consultant

• 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:

• Undergrad or Postgraduate degree
• Lead auditor experience (QSR, ISO 13485, MDSAP)
• Experience with IVDs and/or device software / AI / SaMD
• Experience delivering training sessions
• Additional language proficiency