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Director, Clinical Quality & Compliance

Heartflow· Clinical
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Hybrid (San Francisco, CA)$215k - $240k + equity + bonusFull-timePosted 1mo ago

About the role

Director responsible for strategic oversight, management, and execution of clinical quality assurance and regulatory compliance programs across pre-market and post-market clinical research initiatives, ensuring FDA IDE and GCP compliance and inspection readiness.

Responsibilities

  • 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 in clinical research programs.
  • Leads Bioresearch Monitoring (BIMO) audit preparation, internal GCP audits, vendor oversight, and external regulatory health authority inspections.
  • Works with internal Clinical Operations and external CRO teams to align study protocols, execution strategies, and trial management with regulatory and quality standards.
  • Establishes clinical trial monitoring protocols and oversees ICFs, site monitoring oversight plans, and TMF quality standards.
  • Partners with Clinical Operations to review regulatory document packages for site greenlighting, ensuring ongoing IRB/EC approvals, protocol amendments, and revised ICFs remain compliant across sites.
  • Manages regulatory compliance workflows for UADE and SAE reporting with strict adherence to FDA 10-day reporting windows, IRB/EC notifications, and safety monitoring plans.
  • Implements oversight for protocol deviations and non-compliance with root-cause analysis (RCA) and CAPA in partnership with Clinical Operations.
  • Establishes quality oversight and compliance metrics for field monitors and study personnel per approved protocol and IFU.
  • Collaborates with Regulatory Affairs to meet post-market obligations, including CER, PMCF, Literature Searches, and PSUR.
  • Contributes to FDA IDE regulatory strategies and submissions.
  • Navigates geographic data governance, data privacy, and cross-border regulatory requirements for multi-site global trials.
  • Participates in process improvement activities within the department and cross-functionally.

Qualifications

  • Deep technical knowledge of FDA IDE regulations, FDA GCP standards, ISO 14155, and medical device labeling requirements.
  • Strong experience collaborating with Internal Clinical Operations to ensure GCP compliance in study management.
  • Hands-on experience hosting FDA BIMO audits and preparing sponsors/vendors for regulatory inspections.
  • Experience reviewing/managing ICFs, IBs, IFUs, PMCF plans, and PSUR compilation.
  • Extensive background managing protocol deviations, CAPA systems, and UADE/SAE safety reporting in regulated trials.
  • Understanding of multi-geographic clinical trial execution, data integrity, and cross-border regulatory considerations.
  • Strong matrix leadership and cross-functional collaboration skills.
  • Attention to detail, accuracy, and quality.
  • Ability to manage multiple tasks in shifting priorities and work in a collaborative team environment.
  • Excellent written and oral English communication skills.
  • Proficiency with Microsoft Office and Google tools.

Skills

Required:FDA IDE regulationsFDA GCP standardsISO 14155BIMO auditsIRB/ECCAPA

Benefits

  • Base salary range $215,000 to $240,000
  • cash bonus
  • equity
  • #LI-Hybrid
Last updated Oct 5, 2026. Interested? Apply on the company site.

About Heartflow

Decisive Coronary Care

Heartflow’s vision is to transform CAD from the leading cause of death into a disease that can be managed for life.

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