Senior Regulatory Affairs Specialist

• Prepare, compile, and submit regulatory applications for the SEA region
• Manage and maintain regulatory approvals, licenses, and registrations, including renewals and updates
• Review and approve product labeling, promotional materials, and change control documents for regulatory compliance
• Assess regulatory impact of product changes and determine requirements for new or updated submissions
• Interface with distributors, consultants, and regulatory agencies during submissions, inquiries, and audits
• Monitor and interpret new and evolving SEA regulations, standards, and guidance documents
• Develop and implement regulatory strategies for new product introductions and existing product modifications
• Maintain accurate and organized regulatory documentation and databases

• Minimum of 3-5 years of experience in Regulatory Affairs within the medical device industry
• Experience in preparing and submitting regulatory applications
• Excellent written and verbal communication skills
• Ability to articulate complex regulatory requirements clearly
• Ability to work independently and as part of a cross-functional team

• Face-to-face collaboration culture
• Learning, growth, and development opportunities
• Equal opportunity employment