Caris Life Sciences · 10 hours ago
Manager - Regulatory Affairs (Hybrid)
Tempe, AZ
Full-time
Hybrid
Senior Level, Lead/Staff
8+ years expCaris Life Sciences is dedicated to transforming cancer care and improving lives through precision medicine. The Manager - Regulatory Affairs will oversee regulatory activities related to medical devices and in vitro diagnostic projects, including developing regulatory strategies and ensuring compliance with health authority submissions.
Artificial Intelligence (AI)BiopharmaBiotechnologyHealth CareLife Science
Responsibilities
Lead as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies
Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change
Prepare documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510(k)s, IDEs, PMAs, supplements, as well as international submissions like technical files for CE marketing and Clinical Performance Studies
Lead pharmaceutical partner interactions on new and sustaining projects including regulatory strategy and pre-submissions
Review and provide regulatory input on analytical and clinical study protocols
Provide support, as needed, for Health Authority inspections, including but not limited to FDA inspections, Pre-Approval Inspections, BIMO or European Notified Body Inspections
Provide guidance to pharmaceutical partners and junior regulatory staff regarding regulatory requirements including indications of risk and approximate timing for approval for planning purposes
Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities
Support compliance activities associated with the Quality Management System to fulfil international and domestic policies and regulations
Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies
Qualification
Required
Bachelor's degree in a science-related area of study
8+ years hands-on submission experience including the development and execution of regulatory strategies for medical device and/or IVD regulated products
Must have knowledge of U.S and European product submission and registration requirements for medical devices and/or IVD regulated products
Strong understanding of product development processes, design controls, and ability to effectively partner cross-functionally to develop and influence sound strategies
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
Master's degree in a science-related area of study
Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, software components of IVD medical devices, and NGS
Experience leading and/or supporting US FDA medical device submissions
Ability to mentor and lead others through challenging circumstances
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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