Senior Lead Specialist, Regulatory Affairs, AKA

About the Company

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Responsibilities

• Manage end-to-end regulatory submissions and product registrations with Thailand regulatory authorities (e.g., Thailand Food and Drug Administration)
• Develop and implement regulatory strategies aligned with business objectives and product launch timelines
• Ensure compliance with pre-market and post-market regulatory requirements, including reporting and documentation updates
• Interpret and apply country-specific regulatory requirements, assessing impact on submissions and approvals
• Support regulatory inspections, audits, and compliance activities
• Assess adverse events and field actions and ensure timely regulatory reporting
• Collaborate with global regulatory, business, marketing, and logistics teams to ensure alignment on submissions, product registration timelines, and regulatory requirements
• Manage regulatory and customs-related inquiries/issues to ensure smooth business operations
• Provide updates and present regulatory progress, timelines, and risks to leadership

Qualifications

• Bachelor's degree in Science, Pharmacy, Biomedical Engineering, or related Engineering discipline
• 3–8 years of experience in Regulatory Affairs within medical devices industry
• Strong knowledge of Thailand regulatory requirements and submission processes
• Familiarity with Quality Management Systems (QMS)
• Fluent in Thai language (mandatory) and strong English communication skills
• Proven ability to work independently in a fast-paced environment
• Strong analytical, problem-solving, and stakeholder management skills

Preferred Qualifications

• Experience in medical device regulatory environment
• Prior exposure to multinational or matrix organisations
• Knowledge of customs and importation regulations
• Experience engaging with regulatory authorities and cross-functional teams