Job Title: Regulatory Intelligence Specialist
Department: Global Regulatory Affairs
Reports to: Sr. Manager, Regulatory Intelligence
Location: Irvine, CA (US Office)

Role Overview

The Regulatory Intelligence Specialist is responsible for executing the global Regulatory Intelligence (RI) process, including collecting, analyzing, and interpreting regulatory information to support internal teams.

Key Responsibilities

• Execute the global Regulatory Intelligence management process

• Maintain the regulatory knowledge management platform

• Provide accurate, up-to-date regulatory information and guidance

• Collaborate with cross-functional teams (RA, QA, ME, R&D, CTM, etc.) to share regulatory insights

• Monitor and assess relevant regulations, standards, guidelines, and trends

• Distribute intelligence on regulatory events, people, and organizations across the company

• Support updates to internal policies and procedures

• Perform additional tasks as assigned

Requirements

Experience

• Minimum 2 years in Regulatory Affairs or Quality within the medical device/pharma industry

• Strong understanding of regulatory frameworks

• Experience in regulatory intelligence programs is a plus

Skills

• Thai language fluency (written and spoken) preferred

• Strong communication and interpersonal skills

• Detail-oriented and analytical

• Proficient in MS Office, database systems, process mapping, and flowcharting

• Able to work independently with minimal supervision

Education

• Bachelor’s degree in Science, Engineering, Biotechnology, or related field

Travel

• Up to 10% annually