Clinical Research, Regulatory Associate (PHX)
About The Position
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)
Nice To Haves
- 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
- coordinates study and site start‑up activities
- coordinates IRB submissions
- coordinates ongoing electronic Trial Master File (TMF) management
- 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
- regularly reviews TMF inventories to identify missing, incomplete, or expiring documents and communicates gaps to study team members
- supports preparation of regulatory submissions
- advises study teams on Good Clinical Practice (GCP), FDA, and applicable regulatory requirements
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
