Regulatory Specialist

Role Overview

We are seeking an experienced Regulatory Affairs Specialist to support regulatory strategy and hands-on execution across Asia-Pacific markets. The role covers a portfolio of medical devices, health supplements, nutraceuticals, functional foods, and cosmetic products, including borderline or hybrid products.

The Specialist will be responsible for regulatory classification, market entry planning, and execution, including preparation and coordination of regulatory submissions, registrations, and notifications, as well as liaison with local regulatory authorities, appointed representatives, and external regulatory service providers, where required.

Key Responsibilities

• Assess regulatory classification and compliance pathways across APAC markets.
• Recommend efficient regulatory routes (e.g. food vs health supplement; notification vs registration).
• Prepare, compile, and support regulatory submissions, registrati...