Back to jobs

Regulatory Intelligence Specialist

Job description

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