Executive Director, Regulatory Affairs

Castle Biosciences Inc. is growing, and we are looking to hire a full-time Executive Director, Regulatory Affairs working from our headquarters in Friendswood, TX. Remote candidates who can work from their home office will also be considered. Start date on or before October 15, 2026.

About Castle Biosciences Inc.

At Castle, it all comes down to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes. Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development.

About the role

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.

Responsibilities

• Shape and execute regulatory strategies and operations supporting product development, commercialization, and compliance.
• Navigate evolving regulatory landscapes and mitigate risk.
• Support product development, lifecycle management, and regulatory submissions across U.S. and international markets.
• Work closely with executive leadership and cross-functional stakeholders to drive strategic objectives.

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.
• Must be legally authorized to work in the United States; Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas.

Benefits

• Excellent annual salary + 35% bonus potential.
• 20 accrued PTO days annually + 10 paid holidays.
• 401K with 100% company match up to 6%.
• 3 health care plan options + company HSA contribution.
• Company stock grant upon hire.

Schedule

• Regular weekday schedule with flexibility to support business needs and interactions with US-based colleagues and international stakeholders across varying time zones.
• Must be able to travel 25% routinely; occasionally more often to meet business needs.