Director, Clinical Quality & Compliance

Job 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 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.
• 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.
• 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.
• Implements systematic oversight for logging, evaluating, and mitigating protocol deviations and non-compliance, ensuring thorough root-cause analysis (RCA) and Corrective and Preventive Actions (CAPA) in partnership with internal Clinical Operations.
• Partners with Clinical Operations to establish quality oversight and compliance metrics ensuring field monitors and study personnel execute the trial strictly per the approved protocol and Instructions for Use (IFU).
• Partners with Regulatory Affairs to ensure post-market regulatory obligations are met, including contribution and review of Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) studies, Literature Searches, and Periodic Safety Update Reports (PSUR).
• Contributes to FDA Investigational Device Exemption (IDE) regulatory strategies and submissions.
• Navigates geographic data governance, data privacy, and cross-border clinical regulatory requirements for multi-site global trials.
• Participates in and leads process improvement activities within the department and cross-functionally alongside Clinical Operations.
• Perform other duties, as necessary.

Skills Needed:

• Deep technical knowledge of FDA IDE regulations, FDA GCP standards, ISO 14155, and medical device labeling requirements.
• Strong experience partnering closely with internal Clinical Operations teams to ensure robust GCP compliance in study management processes.
• Direct hands-on experience hosting FDA BIMO audits and preparing sponsors/vendors for regulatory health authority inspections.
• Demonstrated expertise reviewing and managing ICFs, IBs, IFUs, PMCF plans, and PSUR compilation.
• Extensive background managing protocol deviations, CAPA systems, and UADE/SAE safety reporting within regulated clinical trials.
• Understanding of multi-geographic clinical trial execution, data integrity, and cross-border regulatory considerations.
• Strong matrix leadership and collaboration skills, with the ability to drive cross-functional compliance.
• Incredible attention to detail, accuracy, and quality.
• Ability to manage multiple tasks and work comfortably in an environment with shifting priorities.
• Ability to work in a collaborative team environment with a willing, all-hands-on-deck attitude.
• Excellent written and oral English communication skills required.
• Proficiency in computer programs, specifically Microsoft Office tools (Word, Excel, PowerPoint) and Google tools.

Educational Requirements & Work Experience:

• 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).
• 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.
• Proven track record of working in close alignment with internal Clinical Operations teams.
• Experience managing CROs and clinical vendors required.