Senior Director, Quality & Regulatory Affairs

Overview

At Lumicell, we'll give you the opportunity to harness all that's within you by working in a mission-driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer.

You will be a part of something groundbreaking as we expand our commercial launch and continue investigations in other cancer indications.

The Senior Director of Quality is a critical leadership role responsible for overseeing the comprehensive quality, compliance, regulatory strategy, and operational excellence of Lumicell's drug/device combination product. This individual will serve as the quality champion — directing the integration of quality management systems, supplier quality, quality engineering, and working with regulatory affairs to ensure products meet all customer and regulatory standards from concept through post-launch.

This position requires a high level of expertise in quality system management, design controls, supplier management, FDA submissions, inspection leadership and regulatory compliance. This is both a hands-on and strategic role with high visibility across the organization ideally suited for a seasoned professional who thrives in a fast-paced start-up environment and is passionate about bringing novel combination products to market safely and efficiently.

Quality, QMS, Inspections, Supplier Quality, Investigational and Post-Market Surveillance

• Serve as the primary point of contact for all quality-related activities, including regulatory compliance, document control, CAPAs, complaints, post-market surveillance, NCMRs, deviations, risk management, supplier quality, design controls, and internal and external audits.
• Maintain and continuously improve a scalable Quality Management System (QMS) to ensure alignment with QMSR, cGMP, 21 CFR Parts 210, 211, and 820, and ISO 13485 across all functional groups supporting FDA-regulated medical devices and drugs.
• Develop and implement quality systems and SOPs for device and drug quality management, ensuring alignment with cGMP and other regulatory standards.
• Oversee all Quality Engineering functions, ensuring that devices and drugs are designed and manufactured in compliance with applicable FDA regulations and ISO standards (ISO 13485, ISO 14971).
• Act as a subject matter expert in design quality and risk management; lead the company's Management Review process.
• Develop and manage quality metrics and quality objectives to monitor performance, inform management decisions, support continuous improvement initiatives, and assist in preparation of regulatory submissions for product approvals.
• Lead supplier quality management for devices and drugs, managing the entire process from selection and onboarding to ongoing performance evaluations of contract manufacturers (CMOs) and other suppliers.
• Direct design control activities, managing robust process validation, risk management, and ensuring compliance from concept through post-launch per 21 CFR 820.30.
• Own and manage the risk management program in accordance with ISO 14971, including hazard analysis and risk/benefit assessments across the product lifecycle.
• Lead the company through FDA inspections, including serving as the primary host and spokesperson during on-site visits; prepare executive leadership and cross-functional teams through mock audits, inspection readiness programs, and establishment inspection readiness assessments.
• Manage all aspects of inspection, including corporate readiness, real-time coordination during the audit, preparation of Form 483 responses, and development and execution of corrective action plans submitted to regulatory agencies.
• Lead and manage post-market surveillance, including device investigations for complaints and field actions, and MDR reporting.
• Support post-market pharmacovigilance programs for the drug component, ensuring timely adverse event reporting and signal detection in compliance with 21 CFR Part 314, part 3 and…