Quality & Regulatory Affairs Consultant

Responsibilities

• Assist consulting teams and clients with the preparation and submission of medical device registration and licensing applications.
• Prepare renewals or amendments for regulatory submissions and support project team leads.
• Develop and leverage knowledge of medical device submission requirements and registration processes.
• Perform client documentation reviews and gap analyses to ensure data acceptability and compliance.
• Conduct research on regulatory issues through web searches and internal library reviews.
• Summarize technical and regulatory information in written reports.
• Handle client inquiries regarding quality assurance and regulatory compliance, including product labeling and audit responses.
• Act as a regulatory support liaison on large-scale consulting projects and with local regulatory authorities.

Requirements

• Bachelor's degree in a Medical, Engineering, or Science field.
• 2-5 years of Quality Assurance or Regulatory Affairs experience within the medical device field.
• Advanced, professional-level written and verbal English communication skills.
• Proficiency with Microsoft Office software.
• Strong multitasking, organization, and prioritization skills.

Preferred Qualifications

• Previous experience in a consulting role.
• Proven experience with device registrations or high attention to detail in regulatory research.

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.