Senior Lead Specialist, Regulatory Affairs, AKA
Core
Provides regulatory strategy and guidance for product launches, pre-market submissions, and post-market compliance for the Thailand healthcare business.
Role type
Senior Lead Specialist, Regulatory Affairs
Builds
Product registrations and regulatory submissions for medical devices in Thailand
Domain
Healthcare / Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy development, Thailand regulatory authority liaison, pre-market and post-market compliance management, adverse event reporting, stakeholder collaboration, customs and importation regulation knowledge
Preferred skills
Medical device regulatory environment experience, multinational organization exposure, QMS familiarity
Technologies
Quality Management Systems (QMS)
Responsibilities
Manage end-to-end regulatory submissions and product registrations with Thailand regulatory authorities, Develop and implement regulatory strategies aligned with business objectives, Ensure compliance with pre-market and post-market regulatory requirements, Interpret and apply country-specific regulatory requirements, 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, Manage regulatory and customs-related inquiries/issues, Provide updates and present regulatory progress, timelines, and risks to leadership
Seniority
Senior, hands-on IC