Senior Lead Specialist, Regulatory Affairs, AKA

Job description

Job Description Summary Provides regulatory strategy and guidance to the Thailand business on healthcare regulatory requirements, including product launches, pre market submissions and registrations, and post market compliance. Liaises closely with global healthcare regulatory authorities. Demonstrates a strong understanding of key business drivers and applies this knowledge to effectively deliver responsibilities. Possesses a thorough understanding of how the team’s work integrates with cross functional teams and contributes to overall organizational objectives. 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. Job Description Roles and 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 / Requirements 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 (nice-to-have) Experience engaging with regulatory authorities and cross-functional teams Desired Characteristics Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Ability to work independently in fast-paced environment with little supervision. Ability to adapt to constant change and influence positive change effectively. Team-oriented and responsive to customer needs. Attention to Detail and Results-Oriented. Ability to understand technical documentation and execute associated procedures Ability to learn regulations effectively Applies several sets of requirements together balancing strategy effectively Inclusion and Diversity GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. Additional Information Relocation Assistance Provided: No