Senior Quality & Regulatory Affairs Consultant

Responsibilities

• Provide expert Quality Assurance and Regulatory Affairs consulting services to medical device clients, helping resolve compliance issues and market-specific inquiries.
• Prepare and review local and international regulatory submissions, including MFDS and FDA 510(k).
• Compile and review technical documentation files to ensure compliance with applicable global regulations.
• Implement and maintain Quality Management Systems (QMS) in accordance with ISO 13485, QSR, MDSAP, and EU regulations.
• Conduct internal and supplier audits for manufacturers, distributors, and vendors.
• Perform regulatory research, classification, and strategy reporting.
• Conduct literature searches and prepare Clinical Evaluation Reports.
• Review labeling and marketing materials for regulatory compliance.

Requirements

• Bachelor's degree in a science discipline (e.g., biomedical engineering, quality engineering, microbiology, or chemistry).
• 5 years of Quality Assurance and Regulatory Affairs industry experience.
• Demonstrated knowledge of global medical device regulations, specifically MFDS, KGMP, MDSAP, and US regulations.
• Proven experience writing and compiling technical documentation.
• Experience with risk management files (ISO 14971).
• Strong interpersonal skills and experience in client-facing roles.
• Fluency in English.

Preferred Qualifications

• Post-graduate degree.
• Lead auditing experience (QSR, ISO 13485, MDSAP).
• Experience with IVDs and/or device software, AI, or SaMD.
• Experience presenting training to professional groups.
• Fluency in additional languages.

About the Company

UL Solutions is a global leader in applied safety science, transforming safety, security, and sustainability challenges into opportunities for customers in more than 110 countries. We deliver testing, inspection, and certification services, alongside software products and advisory offerings, to support product innovation and business growth.