Senior Quality & Regulatory Affairs Consultant

Responsibilities

• Provide expert Quality Assurance and Regulatory Affairs consulting services to medical device clients.
• Prepare and review local and international regulatory submissions, including MFDS and FDA 510(k).
• Implement and maintain Quality Management Systems (QMS) in compliance 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.
• Review technical documentation, labeling, and marketing materials for regulatory compliance.
• Assist clients in addressing and responding to deficiencies identified by regulatory authorities.

Requirements

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

Preferred Qualifications

• Post-graduate degree.
• Lead auditing experience (QSR, ISO 13485, MDSAP).
• Experience preparing Clinical Evaluation Reports.
• Experience with medical device software or SaMD.
• Experience delivering professional training to 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 and advisory offerings, to support product innovation and business growth. Our mission is to advance safety and help customers navigate global markets and complex supply chains responsibly.