Senior Regulatory Affairs Specialist

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

As a Senior Regulatory Affairs Specialist, you will help shape regulatory strategy and operations across a growing Software as a Medical Device (SaMD) portfolio.
You will support products throughout their lifecycle, from development and submissions through launch and post-market activities.
The role combines hands-on regulatory execution, strong documentation discipline, and cross-functional collaboration.
You will work closely with Quality, Engineering, Product, Clinical, and Legal teams to ensure regulatory requirements are translated into practical actions.
Your work will contribute directly to compliant product development, efficient market access, and sustained inspection and audit readiness.
This is an opportunity to join a fast-moving digital health environment where regulatory expertise can have a meaningful impact on innovative health technologies.