Clinical Research, Regulatory Associate

castlebiosciences; Phoenix (AZ); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Excellent Annual Salary + 20% Bonus 潜t

20 Accrued PTO Days Annually + 10 Paid

401K with 100% Company Match up to 6%

3 Health Care Plan Options + Company H

Company Stock Grant Upon Hire

Job summary

Castle Biosciences Inc. seeks a full-time Regulatory Associate to support day-to-day regulatory activities for assigned clinical studies at our Phoenix, AZ office. The role focuses on site outreach, study start-up, IRB submissions, and TMF management in a fast-paced medical device environment.

You will review regulatory documents, ensure completeness and compliance, and contribute to regulatory submissions while advising study teams on GCP, FDA, and global requirements.

Qualifications

• Bachelor's degree in a scientific, engineering, regulatory, or related field preferred, or demonstrated 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. (21 CFR 820, 21 CFR 812), European (EU MDR 2017/745), and/or other global medical device regulations and standards (ISO 13485, ISO 14971, ISO 14155)
• Experience supporting regulatory submissions (e.g., 510(k), De Novo, Technical Documentation, IDE) preferred

Responsibilities

• Organizes and supports the day-to-day regulatory activities for assigned clinical studies
• Coordinates site outreach, study start-up activities, IRB submissions, and TMF management
• Reviews TMF inventories and communicates gaps to study team members
• Supports preparation of regulatory submissions and advises study teams on GCP, FDA, and applicable regulatory requirements

Skills

Regulatory affairs

Clinical research

FDA/21 CFR knowledge

GCP compliance

Problem solving

Education

Bachelor's degree in scientific/engineering/regulatory field

Equivalent experience in regulatory activities

Tools

CTMS

TMF management

Microsoft Office

Job description

Full‑time Clinical Research, Regulatory Associate

Working from our Phoenix, AZ office location, start date August 1, 2026.

Why Castle Biosciences?

Castle Biosciences Inc. is growing and we are looking to hire a full‑time Clinical Research, Regulatory Associate.

Exceptional Benefits Package

• Excellent Annual Salary + 20% 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 A Regulatory Associate

The Regulatory Associate organizes and supports the day‑to‑day regulatory activities for assigned clinical studies. This role coordinates site outreach, study and site start‑up activities, IRB submissions, and ongoing electronic Trial Master File (TMF) management. A typical day includes collecting and reviewing critical regulatory documents to support study start‑up, maintenance, and close‑out, ensuring documents submitted by CRAs are complete, compliant, and filed accurately in CTMS or TMF systems. The Regulatory Associate regularly reviews TMF inventories to identify missing, incomplete, or expiring documents and communicates gaps to study team members. Serving as a regulatory resource, this role supports preparation of regulatory submissions and advises study teams on Good Clinical Practice (GCP), FDA, and applicable regulatory requirements.

Requirements

• Bachelor's degree in a scientific, engineering, regulatory, or related field preferred, or demonstrated equivalent experience supporting medical device regulatory activities
• Minimum of 1 year of experience in medical device regulatory affairs, clinical research, or related regulated industry required
• Familiarity with medical device product development lifecycle, including design controls and risk management processes
• Working knowledge of U.S. (e.g., 21 CFR 820, 21 CFR 812), European (e.g., EU MDR 2017/745), and/or other global medical device regulations and standards (e.g., ISO 13485, ISO 14971, ISO 14155)
• Experience supporting regulatory submissions (e.g., 510(k), De Novo, Technical Documentation, IDE) preferred

Schedule

• Monday‑Friday, 40 hour work week, working on‑site from our Phoenix, AZ office, flexible hours between 7am-5pm.

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].