The Director, Clinical Quality & Compliance is responsible for the strategic oversight, management, and execution of clinical quality assurance and regulatory compliance programs across pre-market and post-market clinical research initiatives. The Director will work closely with internal Clinical Operations teams and cross-functional partners to support and monitor compliance, ensure adherence with FDA IDE requirements and Good Clinical Practice (GCP), and maintain inspection readiness across all studies, both internally managed and externally initiated or managed.
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.
A reasonable estimate of the base salary compensation range is $215,000 to $270,000, cash bonus, and equity. #LI-Hybrid
