Senior Regulatory Affairs Specialist

This is a fully remote position, open to applicants in Malaysia.

📋 Description

• Prepare, compile, and submit regulatory applications for the SEA region.

• Manage and uphold regulatory approvals, licenses, and registrations, including their renewals and updates.

• Review and approve product labeling, promotional materials, and change control documents to ensure regulatory compliance.

• Evaluate the regulatory implications of product modifications and define requirements for new or revised submissions.

• Collaborate with distributors, consultants, and regulatory agencies during submissions, inquiries, and audits.

• Keep abreast of and interpret new and evolving regulations, standards, and guidance documents in the SEA region.

• Formulate and execute regulatory strategies for the introduction of new products and modifications to existing products.

• Maintain precise and organized regulatory documentation and databases.

⛳️ Requirements

• A minimum of 3-5 years of experience in Regulatory Affairs within the medical device sector.

• Proven experience in preparing and submitting regulatory applications.

• Outstanding written and verbal communication abilities.

• Capability to clearly articulate complex regulatory requirements.

• Ability to work both independently and collaboratively as part of a cross-functional team.

🏝️ Benefits

• Face-to-face collaboration culture.

• Opportunities for learning, growth, and development.

• Commitment to equal opportunity employment.