Job summary
Job post source
This job is directly from Caris Life Sciences
Job overview
The Regulatory Affairs Analyst at Caris Life Sciences ensures regulatory compliance for products, playing a critical role in securing approvals and maintaining standards to support the company's mission in precision medicine and cancer care.
Responsibilities and impact
The analyst manages regulatory submissions for global approvals, applies regulatory standards to product strategies, leads communications with regulatory agencies, advises on regulatory requirements, authors SOPs, and supports product lifecycle planning to ensure compliance and facilitate product development.
Experience and skills
Requires a Bachelor's degree in Engineering or Science, at least 3 years of experience in FDA regulated industries and Regulatory Affairs, with knowledge of 21 CFR Part 820, ISO 13485, and MDSAP; RAC certification or advanced degree preferred.
Work environment and culture
Caris Life Sciences values innovation, compassion, and purpose, fostering a mission-driven environment focused on transforming cancer care and improving human health.
Company information
Caris Life Sciences is a leader in precision medicine and molecular science, pioneering AI-driven cancer diagnostics and expanding into broader healthcare innovation.
Job location and travel
Hybrid work arrangement with some travel and occasional evening, weekend, or holiday work required; primarily desk-based with some lab and data center exposure.
Unique job features
The role involves working on cutting-edge regulatory submissions for innovative medical products, contributing to a mission-driven company focused on transforming cancer care through precision medicine.
Company overview
Caris Life Sciences is a leading biotechnology company specializing in molecular profiling and precision medicine. They generate revenue through diagnostic services, including comprehensive genomic profiling and AI-driven molecular testing, which help in personalized cancer treatment. Founded in 2008, Caris has pioneered innovative approaches in oncology, integrating cutting-edge technology to improve patient outcomes. Their commitment to advancing precision medicine has positioned them as a key player in the biotech industry.
How to land this job
Tailor your resume to emphasize your experience with FDA regulatory compliance, including knowledge of 21 CFR Part 820, ISO 13485, and MDSAP standards, as these are critical for the Regulatory Affairs Analyst role at Caris Life Sciences.
Highlight your skills in preparing complex regulatory submissions such as IDE, 510(k), PMA, and international filings like Shonin and Design Dossier, showcasing your ability to navigate global regulatory frameworks.
Apply through multiple platforms including Caris Life Sciences’ official corporate careers page and LinkedIn to maximize your application visibility and chances of being noticed.
Connect with current employees in the Regulatory Affairs or Compliance divisions at Caris Life Sciences on LinkedIn; use ice breakers like commenting on recent regulatory initiatives by Caris or expressing your passion for precision medicine and how it aligns with their mission.
Optimize your resume for ATS by incorporating keywords from the job description such as 'regulatory compliance,' 'submission preparation,' 'FDA approvals,' 'risk-benefit analysis,' and 'SOP development' to ensure it passes automated screening effectively.
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