Director, International Regulatory Affairs

Description:

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Director, International Regulatory Affairs based in United States.

This senior leadership role will shape global regulatory strategy for an innovative healthcare portfolio focused on advancing early cancer detection.

You will lead international commercialization efforts across Europe, Asia-Pacific, the Middle East, and the UK, helping bring complex diagnostic technologies to patients worldwide.

The position combines strategic leadership, regulatory expertise, executive influence, and hands‑on oversight of critical submissions and product registrations.

You will partner with senior leaders across R&D, Clinical, Quality, Manufacturing, and Commercial functions to embed regulatory considerations into business and portfolio decisions.

The role also offers the opportunity to influence evolving regulatory policy and represent the organization through industry forums and global regulatory working groups.

As a global-facing leader, you will help strengthen regulatory capabilities, modernize processes, and develop the next generation of regulatory talent.

The position is ideal for an accomplished regulatory professional who thrives in complex, highly regulated environments and can balance innovation, compliance, and business priorities.