Suru ยท 2 days ago
Clinical Specialist
United States
Contract
Remote
Lead/StaffSuru is seeking a Principal Pre-Clinical Submission Specialist to lead and execute early-stage regulatory and clinical-enabling activities for cardiac electrophysiology systems. This highly technical role involves managing pre-clinical studies, collaborating with physicians, and ensuring regulatory submissions are supported by robust data interpretation.
Staffing & Recruiting
Hiring Manager
Steven Scott
Responsibilities
Serve as the principal pre-clinical submission lead supporting early regulatory and clinical pathways
Manage and coordinate activities with physicians, electrophysiologists, and clinical trial sites
Support and oversee pre-clinical and animal studies, including interaction with animal labs and use of specialized cardiac equipment
Work directly in electrophysiology lab environments, supporting trials and capturing procedural and outcome data
Interpret and translate cardiac electrophysiology data from pre-clinical and early clinical studies into regulatory-ready documentation
Support IDE-enabling and pre-submission activities, including data preparation, technical narratives, and FDA-facing materials
Collaborate cross-functionally with R&D, clinical, and regulatory leadership to ensure alignment on study design and data requirements
Travel on-site to clinical trial locations as needed (approximately once per month), with additional on-site presence in Marlborough during active trials
Qualification
Required
Strong background in cardiac electrophysiology, with hands-on exposure to EP lab environments
Prior experience operating in or supporting electrophysiology labs during pre-clinical or early clinical trials
Experience working directly with cardiac electrophysiologists and physicians
Demonstrated experience capturing, interpreting, and presenting EP and cardiac mapping data
Background supporting implantable or minimally invasive cardiac devices
Understanding of pre-clinical and early clinical trial execution, including animal studies
Preferred
Experience with cardiac mapping systems
Exposure to IDE-enabling or pre-submission regulatory activities
Experience supporting trials for electrophysiology or catheter-based cardiac systems
Ability to operate independently as a technical and clinical leader in early-stage programs
Company
Suru
Suru is a specialized recruiting firm focused on delivering top-tier talent for direct hire and temporary placements across a wide range of industries.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase