Executive Director, Regulatory Affairs

Job Description

Job Description

Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood! Learn more at 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 Potential20 Accrued PTO Days Annually + 10 Paid Holidays401K with 100% Company Match up to 6%3 Health Care Plan Options + Company HSA ContributionCompany Stock Grant Upon HireA DAY IN THE LIFE OF THE Executive Director, Regulatory AffairsAs 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/credentials10+ years of progressive regulatory affairs experience at a medical device or other healthcare organizationAt least 3 years in a management position with regulatory staff oversight responsibilitiesExperience with C-suite and Board-level interactionDeep understanding of applicable regulatory guidelines and requirementsCurrent understanding of the regulatory environment in laboratory diagnostics and medical devices *Please see the full job description at the end of the job ad.SCHEDULEThis 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.READY TO JOIN OUR BIOTECH TEAM?We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon!Castle Biosciences Awards and Research Developments!WORK AUTHORIZATIONAll 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 View email address on us.fitly.work 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

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