Senior Quality & Regulatory Affairs Consultant

UL Solutions · Republic of

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

A global leader in applied safety science, UL Solutions (NYSE: ULS) transforms safety, security and sustainability challenges into opportunities for customers in more than 110 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers’ product innovation and business growth. The UL Mark serves as a recognized symbol of trust in our customers’ products and reflects an unwavering commitment to advancing our safety mission. We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future. Our science is your advantage.

Provide Quality and/or Regulatory consulting services, either independently or under the guidance of a Lead QA/RA Consultant or Consultant Manager.

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