Director, Clinical Quality & Compliance
Core
Strategic oversight and execution of clinical quality assurance and regulatory compliance programs across pre-market and post-market clinical research initiatives for an AI-driven non-invasive cardiac test.
Role type
Director, Clinical Quality & Compliance (Medical Device)
Builds
Regulatory compliant clinical trials and post-market surveillance programs for Heartflow FFRCT Analysis
Domain
Medical Technology / Cardiovascular Diagnostics / Clinical Research
Deliverable
client delivery
Required skills
FDA IDE regulations, FDA GCP standards, ISO 14155, medical device labeling, Bioresearch Monitoring (BIMO) audits, Investigator's Brochures (IB), Informed Consent Forms (ICFs), Trial Master File (TMF), Unanticipated Adverse Device Effects (UADE), Serious Adverse Event (SAE) reporting, protocol deviations, CAPA, CRO management, multi-geographic trial execution
Preferred skills
Master's/PhD/PharmD/RN, BIMO audit readiness leadership, FDA IDE submission experience
Technologies
Microsoft Office, Google tools
Responsibilities
Lead clinical quality and regulatory compliance strategies; ensure end-to-end clinical trial compliance with FDA GCP and ISO 14155; oversee medical device labeling requirements; author and review Investigator's Brochures; lead BIMO audit preparation and external regulatory inspections; manage UADE/SAE reporting workflows; implement oversight for protocol deviations and CAPA; partner with Clinical Operations on site greenlighting and IRB/EC approvals; contribute to FDA IDE regulatory strategies; navigate geographic data governance and cross-border regulatory requirements.
Seniority
Director, strategic oversight & cross-functional leadership
