Regulatory Affairs Specialist

Outsized is building a network of Regulatory Affairs professionals within the medical technology and healthcare sectors. As clinical trials and product innovation accelerate across the region, we are connecting specialists who can help global and regional firms navigate complex approval processes and regulatory frameworks.

Who We’re Looking For

We want to engage experienced Regulatory Affairs professionals who have supported the registration, compliance, and approval of medical devices, diagnostics, and digital health products across multiple markets.

Typical Experience Includes

• Preparing and managing technical documentation for global and local submissions (FDA, CE, TGA, HSA, etc.).
• Supporting end-to-end product registration and approval processes across Asia-Pacific.
• Collaborating with Quality, Clinical, and R&D teams to ensure compliance from design to market release.
• Monitoring and interpreting changing regulatory requirements across countries.
• Managing audits, product variations, and post-market surveillance.

Ideal Background

Why Join the Outsized Network

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