Castle Biosciences Earns Top Workplaces USA Award for Phoenix Pittsburgh and Friendswood!
Learn more at
Castle Biosciences Inc. is growing and we are looking to hire a full-time Clinical Research Regulatory Associate working from our Phoenix AZ office location with a start date of May 15 2026.
Why Castle Biosciences
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 daytoday regulatory activities for assigned clinical studies. This role coordinates site outreach study and site startup activities IRB submissions and ongoing electronic Trial Master File (TMF) management. A typical day includes collecting and reviewing critical regulatory documents to support study startup maintenance and closeout 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
- Bachelors 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
*Please see the full job description at the end of the job ad.
SCHEDULE
- Monday-Friday 40 hour work week working on-site from our Phoenix AZ office flexible hours between 7am-5pm.
READY TO JOIN OUR BIOTECH TEAM
We truly appreciate your time. If this feels like the right opportunity for you wed love for you to complete our mobile-friendly application. Were excited to learn more about you and look forward to connecting soon!
Castle Biosciences Awards and Research Developments!
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 doesnt just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a persons 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 .
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
Required Experience:
IC
Castle Biosciences Earns Top Workplaces USA Award for Phoenix Pittsburgh and Friendswood! Learn more at Castle Biosciences Inc. is growing and we are looking to hire a full-time Clinical Research Regulatory Associate working from our Phoenix AZ office location with a start date of May 15 2026.Why Ca...
Castle Biosciences Earns Top Workplaces USA Award for Phoenix Pittsburgh and Friendswood!
Learn more at
Castle Biosciences Inc. is growing and we are looking to hire a full-time Clinical Research Regulatory Associate working from our Phoenix AZ office location with a start date of May 15 2026.
Why Castle Biosciences
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 daytoday regulatory activities for assigned clinical studies. This role coordinates site outreach study and site startup activities IRB submissions and ongoing electronic Trial Master File (TMF) management. A typical day includes collecting and reviewing critical regulatory documents to support study startup maintenance and closeout 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
- Bachelors 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
*Please see the full job description at the end of the job ad.
SCHEDULE
- Monday-Friday 40 hour work week working on-site from our Phoenix AZ office flexible hours between 7am-5pm.
READY TO JOIN OUR BIOTECH TEAM
We truly appreciate your time. If this feels like the right opportunity for you wed love for you to complete our mobile-friendly application. Were excited to learn more about you and look forward to connecting soon!
Castle Biosciences Awards and Research Developments!
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 doesnt just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a persons 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 .
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
Required Experience:
IC
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