- Posted 18 June 2025
- LocationIrvine
- Job type Permanent
- Reference218331
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
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Execute the global Regulatory Intelligence management process
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Maintain the regulatory knowledge management platform
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Provide accurate, up-to-date regulatory information and guidance
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Collaborate with cross-functional teams (RA, QA, ME, R&D, CTM, etc.) to share regulatory insights
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Monitor and assess relevant regulations, standards, guidelines, and trends
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Distribute intelligence on regulatory events, people, and organizations across the company
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Support updates to internal policies and procedures
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Perform additional tasks as assigned
Requirements
Experience
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Minimum 2 years in Regulatory Affairs or Quality within the medical device/pharma industry
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Strong understanding of regulatory frameworks
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Experience in regulatory intelligence programs is a plus
Skills
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Thai language fluency (written and spoken) preferred
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Strong communication and interpersonal skills
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Detail-oriented and analytical
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Proficient in MS Office, database systems, process mapping, and flowcharting
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Able to work independently with minimal supervision
Education
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Bachelor’s degree in Science, Engineering, Biotechnology, or related field
Travel
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Up to 10% annually