Executive Director, Regulatory Affairs

Castle Biosciences•Friendswood, TX

2d•Hybrid

About The Position

As the regulatory leader for a molecular diagnostics laboratory and medical device manufacturer, the Executive Director shapes and executes regulatory strategies and operations that support product development, commercialization, and ongoing compliance with regulatory requirements. Working closely with executive leadership and cross-functional stakeholders, this role navigates evolving regulatory landscapes, mitigates risk, and helps drive the organization's strategic objectives. The Executive Director combines strategic leadership with a hands-on approach, supporting product development, commercialization, lifecycle management, and regulatory submissions across U.S. and international markets.

Requirements

Bachelor's Degree or higher or other professional degree/credentials
10+ years of progressive regulatory affairs experience at a medical device or other healthcare organization
At least 3 years in a management position with regulatory staff oversight responsibilities
Experience with C-suite and Board-level interaction
Deep understanding of applicable regulatory guidelines and requirements
Current understanding of the regulatory environment in laboratory diagnostics and medical devices
All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.

Responsibilities

Shapes and executes regulatory strategies and operations that support product development, commercialization, and ongoing compliance with regulatory requirements.
Works closely with executive leadership and cross-functional stakeholders.
Navigates evolving regulatory landscapes.
Mitigates risk.
Helps drive the organization's strategic objectives.
Supports product development, commercialization, lifecycle management, and regulatory submissions across U.S. and international markets.