Manager – Regulatory Affairs
Caris Life Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Tempe • Arizona • Texas • United States
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About the role
- Responsible for regulatory activities related to medical devices / in vitro diagnostic projects and applicable health authority submissions.
- 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 including 510(k)s, IDEs, PMAs, international submissions 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 for Health Authority inspections, including FDA inspections and Pre-Approval Inspections.
- Provide guidance to pharmaceutical partners and junior regulatory staff regarding regulatory requirements including indications of risk and planning for approval.
- Ensure regulatory compliance with relevant regulations and effectively manage timely submissions.
- Support compliance activities associated with the Quality Management System to fulfil international and domestic policies and regulations.
- Effectively communicate, prepare, and negotiate internally with cross-functional teams and externally with regulatory agencies.
Requirements
- 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.
- 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.
- Master’s degree in a science-related area of study (preferred).
- Demonstrate in-depth understanding of sophisticated technical/scientific principles related to IVD reagent chemistry, laboratory automation, software components of IVD medical devices, and NGS (preferred).
- Experience leading and/or supporting US FDA medical device submissions (preferred).
- Ability to mentor and lead others through challenging circumstances (preferred).
Benefits
- All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
- Periodic travel and some evenings, weekends and/or holidays may be required.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory activitiesregulatory guidanceregulatory strategies510(k)IDEPMAclinical performance studiesproduct submissiondesign controlsIVD reagent chemistry
Soft Skills
effective communicationtime managementproject planningindependent workownershipmentoringcross-functional collaborationnegotiationleadershipproblem-solving