Executive Director, Regulatory Affairs

Castle Biosciences, Inc.; Friendswood (TX); Hybrid; USD 150,000 - 190,000; Full time

Benefits offered by this job

Bonus potential

PTO and holidays

401K match

Health plan options

Stock grant

Job summary

Castle Biosciences Inc. seeks an Executive Director, Regulatory Affairs to shape regulatory strategy for diagnostics and devices. You will lead submissions, lifecycle management, and cross‑functional alignment with executives, steering compliance across US and international markets.

The role requires 10+ years in regulatory affairs, 3+ years in leadership, and strong interactions with the C‑suite; remote work is considered, with travel up to 25% as needed.

Qualifications

• Bachelor's degree or higher in a related field; extensive regulatory affairs background.
• Minimum 10+ years in regulatory affairs within medical devices or diagnostics.
• 3+ years in a management role with regulatory staff oversight.

Responsibilities

• Lead regulatory strategy for US and international submissions and lifecycle management.
• Partner with executives and cross-functional teams to ensure compliance and product timelines.
• Direct interactions with C-suite and Board on regulatory matters.

Skills

Bachelor's Degree

10+ years regulatory affairs

3+ years management

C-suite interaction

Regulatory guidelines

Lab diagnostics experience

Education

Bachelor's Degree or higher

Job description

Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood!

Learn more at www.CastleBiosciences.com

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 (Will consider remote candidates who can work from their home office). with a start date on or before October 15, 2026.

Why Castle Biosciences?

Exceptional Benefits Package:

• 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

A DAY IN THE LIFE OF THE Executive Director, Regulatory Affairs

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.

• 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

*Please see the full job description at the end of the job ad.

SCHEDULE

• This position generally maintains a regular weekday schedule. Flexibility is required 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.

WORK AUTHORIZATION

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.

ABOUT CASTLE BIOSCIENCES INC.

At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is 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.

Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail [e-mail].

This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

** No third-party recruiters, please