Regulatory Affairs Analyst (Hybrid)
Caris Life SciencesHighlight
Summary
About the Role
About You
- Bachelor's degree in science-related area of study.
- 3+ years’ experience in a regulated environment, preferably with 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 standards.
- Understanding of document control requirements and design control.
- Ability to work independently and manage processes, projects, and timelines.
- Proficient with MS Office programs including Word, PowerPoint, Excel, Visio, Outlook, and Project.
- Effective time management and project planning skills.
- Experience reading and writing documentation in a scientific setting.
- Experience in writing Health Authority regulatory submissions.
Caris Life Sciences® (Caris) is the leading next-generation TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced artificial intelligence (AI) and machine learning algorithms, Caris has created the large-scale, clinico-genomic database and computing capability needed to analyze and unravel the molecular complexity of disease. This convergence of sequencing power, big data and AI technologies provides an unmatched platform to deliver the next-generation of precision medicine tools for early detection, diagnosis, monitoring, therapy selection and drug development. Headquartered in Irving, Texas, Caris has offices in Phoenix, New York, Tokyo, Japan and Basel, Switzerland. Caris or its distributor partners provide services in the U.S., Europe, Asia and other international markets.