Clinical Research, Regulatory Associate

Job Overview Castle Biosciences Inc. is growing, looking to hire a full‑time Clinical Research, Regulatory Associate. The position is located in our Phoenix, AZ office with a start date of August 1, 2026. Why Castle Biosciences? Exceptional Benefits Package: Excellent Annual Salary + 20% Bonus Potential , 20 Accrued PTO Days + 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 The Regulatory Associate organizes and supports day‑to‑day regulatory activities for assigned clinical studies, coordinating site outreach, study and site start‑up, IRB submissions, and ongoing TMF management. Responsibilities include collecting and reviewing regulatory documents, ensuring completeness and compliance in CTMS or TMF systems, reviewing TMF inventories to identify gaps, and serving as a regulatory resource to support submissions and advise on GCP, FDA, and applicable regulations. Requirements Bachelor's degree in a scientific, engineering, regulatory, or related field preferred, or equivalent experience supporting medical device regulatory activities. Minimum of 1 year of experience in medical device regulatory affairs, clinical research, or related regulated industry. Familiarity with medical device product development lifecycle, including design controls and risk management processes. Working knowledge of U.S., European, and/or other global medical device regulations and standards (e.g., 21 CFR 820, 21 CFR 812, EU MDR 2017/745, ISO 13485, ISO 14971, ISO 14155). Experience supporting regulatory submissions such as 510(k), De Novo, Technical Documentation, IDE preferred. Schedule Monday‑Friday, 40‑hour work week, on‑site at Phoenix office, flexible hours between 7 am‑5 pm. Work Authorization All candidates must be legally authorized to work in the United States. Castle Biosciences does not sponsor H‑1B visas, OPT, or employment‑related visas. Equal Opportunity Employer Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. Reasonable Accommodation If you have a disability and need a reasonable accommodation to apply, please email View email address on click.appcast.io. Accessibility Notice This email was created exclusively to assist disabled job seekers whose disability prevents them from applying online. Only messages left for this purpose will be returned. Other messages will not receive a response. Application We 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 about you and look forward to connecting soon! #J-18808-Ljbffr Castle Biosciences, Inc.