Caris Life Sciences · 13 hours ago
Regulatory Affairs Analyst (Hybrid)
Irving, TX
Full-time
Hybrid
Mid Level
3+ years expCaris Life Sciences is dedicated to transforming cancer care and improving lives through precision medicine. The Regulatory Affairs Analyst will be responsible for regulatory activities related to medical devices and in vitro diagnostic products, supporting compliance activities and regulatory submissions both in the US and internationally.
Artificial Intelligence (AI)BiopharmaBiotechnologyHealth CareLife Science
Responsibilities
Provide support for product development, manufacturing and distribution in compliance with applicable regional regulations
Support compilation, preparation, review and submissions of Health Authority regulatory applications in a timely manner. This can include US applications such as IDE, 510(k)s and PMA supplements, as well as international submissions like technical files for CE marking and Clinical Performance Studies. Support review of changes in products, product specifications, and manufacturing processes to assess the regulatory implications of the change
Support continued regulatory compliance throughout product’s life cycle
Provide support, as needed, for Health Authority Audits like FDA Inspections, Pre-Approval Inspections, BIMO or European Notified Body inspections
Support regulatory compliance with relevant regulations and effectively manage timely submissions to the appropriate regulatory authorities
Support compliance activities associated with the Quality Management System to fulfill international and domestic policies and regulations, including lifecycle management and design control requirements
Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies
Qualification
Required
Bachelor's degree in science-related area of study
3+ years' experience in a regulated environment, preferably moderate to high-risk devices (US Class II or Class III), in a regulatory or quality function
Knowledge of domestic and international medical devices, in-vitro diagnostic regulations, or pharmaceutical including standards and guidance documents
An understanding of document control requirements, design control, and experience working in a regulated environment
Ability to work independently, taking ownership for the management of processes, projects, and timelines
Proficient with MS Office computer programs, including Word, Power Point, Excel, Visio, Outlook and Project
Effective time management & project planning skills
Preferred
Experience reading and writing documentation in a scientific setting
Experience in writing Health Authority regulatory submissions
Company
Caris Life Sciences
Caris Life Sciences develops molecular profiling and AI-driven technologies to support precision medicine in oncology.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.86BKey Investors
BraidwellOrbiMedSixth Street
2025-06-18IPO
2025-04-07Private Equity· $168M
2023-01-19Debt Financing· $400M
Leadership Team
Luke Power
Chief Financial Officer
Brian Stengle
SVP, Chief Marketing Officer
Recent News
Labiotech UG
2026-01-17
2026-01-14
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