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