Caris Life Sciences

Regulatory Affairs Analyst

Caris Life Sciences

full-time

Posted on:

Location Type: Hybrid

Location: Tempe • Arizona • Texas • United States

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About the role

  • 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.

Requirements

  • 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.
Benefits
  • Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions ) and reference verification.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory compliancedocument controldesign controlproduct specificationsregulatory submissionsHealth Authority applicationsIDE510(k)PMA supplementsclinical performance studies
Soft Skills
effective communicationtime managementproject planningindependent workownershipnegotiationcross-functional collaboration