Senior Quality & Regulatory Affairs Consultant

1h1 hour ago

UL Solutions

KR · Full-time

About this role

UL Solutions seeks a Senior Quality & Regulatory Affairs Consultant to provide expert consulting services in the medical device sector. This role leverages deep regulatory experience to support clients with Quality Assurance and compliance requests globally.

Day-to-day responsibilities include preparing and reviewing regulatory submissions such as MFDS and FDA 510(k) on behalf of manufacturers. The consultant compiles technical documentation, performs market-specific research, and generates peer-reviewed reports for standard and nuanced environments.

Working within a team of QA/RA consultants, the role involves implementing Quality Management Systems to ISO 13485, MDSAP, and EU regulations. The consultant also conducts internal and supplier audits, manages gap closure and remediation, and advises on labeling and marketing materials.

This position offers the opportunity to work on diverse projects across multiple regulatory markets, including Korea, the US, and MDSAP countries. Consultants grow their expertise by addressing deficiencies, guiding testing requirements, and contributing to client success in a global safety science leader.

Requirements

Bachelor's degree in a science discipline such as biomedical engineering, Quality engineering, microbiology, or chemistry
5 years of Quality Assurance and Regulatory Affairs industry experience, ideally at a team lead or supervisory level
Demonstrated knowledge of global medical device regulations, especially MFDS, KGMP, MDSAP countries, and/or US
Experience with writing and compiling technical documentation
Experience with risk management files (ISO 14971)
Client-facing experience and strong interpersonal skills
Fluency in English

Responsibilities

Provide Quality and Regulatory consulting services independently or under oversight of a Lead QA/RA Consultant
Prepare and review local or international regulatory submissions (e.g., MFDS, FDA 510(k)) on behalf of manufacturers
Compile and review technical documentation files for compliance to applicable regulations and raise concerns
Perform research on regulatory affairs for standard or nuanced market environments and generate peer-reviewed reports
Implement new Quality Management Systems to ISO 13485, QSR, MDSAP, EU regulations, and analyze existing QMS for gap closure and remediation
Conduct internal audits and supplier audits for manufacturers, distributors, and vendors
Prepare regulatory classification and strategy pathway reports, and assist in responding to deficiencies from regulatory authorities
Review and advise on labeling and marketing materials, including written documents and websites