Hiring: Director, Clinical Quality & Compliance Company: Heartflow Location: San Francisco, CA Job Posted Time: 2026-09-16 11:19:52 Target Skills & Keywords : GCP, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Quality Assurance, Regulatory Compliance About the job Experience: •Demonstrated minimum of 8 years relevant experience in clinical quality assurance and regulatory affairs within the medical device, biotech, or combination product industries. •Demonstrated experience leading BIMO audit readiness and FDA IDE submissions preferred. •Demonstrated success in working in close alignment with internal Clinical Operations teams. Required Skills: •Leads clinical quality and regulatory compliance strategies and initiatives across pre-market and post-market internal and external clinical programs. •Ensures robust end-to-end clinical trial compliance with FDA Good Clinical Practice (GCP) guidelines (21 CFR Parts 50, 56, 312, 812) and ISO 14155. •Oversees medical device labeling requirements, ensuring full compliance with FDA regulations and international labeling standards for post-market and investigational devices. •Authors, reviews, and maintains Investigator’s Brochures (IB) for investigational medical devices being used in clinical research programs. •Leads Bioresearch Monitoring (BIMO) audit preparation, internal GCP audits, vendor oversight, and external regulatory health authority inspections. •Works closely with internal Clinical Operations and external CRO teams to ensure study protocols, execution strategies, and trial management practices align with regulatory and quality standards. •Partners with Clinical Operations to review regulatory document packages required for site greenlighting, ensuring ongoing Institutional Review Board (IRB) / Ethics Committee (EC) approvals, protocol amendments, and revised ICF implementations remain compliant across all sites. •Manages regulatory compliance oversight for Unanticipated Adverse Device Effects (UADE) and Serious Adverse Event (SAE) reporting workflows, ensuring strict adherence to FDA 10-day reporting windows, IRB/EC notifications, and safety monitoring plans. Qualifications: •Establishes clinical trial monitoring protocols and oversees key study deliverables, including Informed Consent Forms (ICFs), site monitoring oversight plans, and Trial Master File (TMF) quality standards. •Minimum of a Bachelor’s degree in Life Sciences, Biomedical Engineering, Clinical Research, or related scientific/health field (Master's, Ph.D., PharmD, or RN preferred). Compensation: •$215,000 - $270,000 / year •A reasonable estimate of the base salary compensation range is $215,000 to $270,000, cash bonus, and equity •A reasonable estimate of the base salary compensation range is $215,000 to $270,000, cash bonus, and equity. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!