Senior Director, Quality & Regulatory Affairs

Lumicell•Waltham, MA

1d•Hybrid

About The Position

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.

Requirements

Bachelor's degree required in scientific, engineering or regulatory discipline (e.g., Biology, Chemistry, Biomedical Engineering, or related field); Master’s degree preferred
Certification as a CQE, CRE, Manager of Quality, and/or Six Sigma Black Belt
Minimum 10+ years of progressive experience in quality assurance within the medical device, with significant leadership experience including managing supplier quality and quality assurance teams across devices and drugs; experience with pharmaceutical and device/drug regulatory affairs is a plus
Minimum 5 years in a director-level or senior leadership role with demonstrated people management responsibilities and scaling the QA/RA organization
Hands-on experience with combination product regulatory frameworks (21 CFR Parts 3 & 4).
Demonstrated track record of successful FDA submissions; IND/NDA, IDE/510(k)/PMA experience required
Comprehensive knowledge of FDA and international regulatory standards applicable to medical devices and pharmaceuticals, including 21 CFR Parts 820 and 210/211, ISO standards, and ICH guidelines
Demonstrated experience leading a company through FDA inspections (e.g., Pre- and Post-approval Inspections, Supplier Inspections, GMP/GCP audits); must have personally served as the primary host or lead during at least one formal regulatory inspection
Proven track record of successfully managing FDA Form 483 observations and Warning Letter responses, including the development and implementation of robust corrective and preventive action (CAPA) plans
Experience designing and executing inspection readiness programs, including mock audits, gap assessments, and staff training across manufacturing, clinical, and laboratory environments.
Proven track record in managing quality systems, strongly preferred in an early-stage/start-up environment, and leading comprehensive quality functions
Experience with electronic QMS (eQMS) platforms, preferably Arena
Familiarity with post-market pharmacovigilance programs for drugs and complaints management for devices, including MDR reporting
Strong leadership skills with the ability to mentor and develop teams.
Excellent problem-solving, organizational, and written and verbal communication skills

Responsibilities

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 applicable post-approval requirements.
Support all quality aspects of Clinical Affairs programs in compliance with 21 CFR 312, 21 CFR 812, and ISO 14155:2020.