Director of Quality Systems and Regulatory Compliance

Director of Quality Systems and Regulatory Compliance We are seeking a strategic leader to join our pioneering molecular diagnostics company, where you will drive the development and implementation of our Quality Management System (QMS) and global regulatory strategies for diagnostic products. Reporting directly to the CEO, you will play a critical role in ensuring our compliance with FDA, ISO 13485, and other international medical device regulations, while fostering a culture of quality and continuous improvement. Company Overview Our Southern California-based company is at the forefront of transforming laboratory diagnostics for infectious diseases. We specialize in high-throughput multiplex testing platforms utilizing our innovative Barcoded Magnetic Bead technology. Our mission is to help laboratories conduct efficient, cost-effective tests for respiratory, gastrointestinal, and COVID-19 diagnoses—all within a single streamlined workflow. As part of our collaborative team, you will contribute to enhancing public health through groundbreaking technology and impactful scientific advancements. Key Responsibilities Develop and maintain a compliant QMS aligned with QSR, ISO 13485:2003, and 21 CFR Part 11 standards. Oversee CAPA, complaint handling, document control, change control, auditing, and risk management activities. Lead Management Reviews and effectively communicate quality performance metrics to the Executive Team. Ensure strict compliance with FDA regulations and international medical device standards. Collaborate with R&D and Clinical Affairs to ensure that validation studies meet regulatory expectations. Oversee FDA establishment registrations, device listings, CE Technical Files, and Notified Body submissions. Act as the primary contact during FDA and ISO/Notified Body inspections and audits. Monitor and adapt to evolving global regulatory requirements and update internal systems accordingly. Lead and develop the quality and regulatory staff through effective training and performance management. Drive quality improvement initiatives and promote cross-functional collaboration within the organization. Preferred Qualifications Advanced degree (e.g., MS, MBA, or PhD) in Chemistry, Biology, Life Sciences, or a related field. 10+ years of relevant experience in Quality or Regulatory Affairs within the medical device or diagnostics industry. 5+ years of leadership experience in a regulated environment. Experience within IVD, life sciences, or medical device settings. Proven leadership skills in building and managing quality and regulatory teams. Experience with FDA and Notified Body inspections in a medical device context. Familiarity with global regulatory submissions and compliance strategies. Required Qualifications Bachelor's degree in Chemistry, Biology, Life Sciences, or a related technical field. 6+ years of experience in Quality or Regulatory Affairs within the medical device or diagnostics sector. 3+ years of leadership experience in a regulated environment. In-depth knowledge of FDA, QSR, ISO 13485, and GMP standards. Track record of successfully implementing and managing QMS and regulatory processes. Strong written and verbal communication skills. Ability to manage multiple priorities and achieve results in a fast-paced environment. Proficiency in Microsoft Office and QMS tools (e.g., Veeva, MasterControl). Willingness to travel up to 20% domestically and internationally. This role primarily involves on-site work in a lab or production environment, and may require physical tasks such as bending, squatting, reaching, and lifting. Candidates should be capable of lifting, pushing, or pulling up to 50 lbs with assistance. Join our fast-paced team environment to collaborate across engineering and manufacturing functions. Compensation and Benefits We offer a competitive salary between $145,000 and $160,000 based on your experience and education level, alongside comprehensive medical, dental, and vision insurance. Additional perks include a 401(k) retirement plan with company match, paid time off, and numerous opportunities for professional growth and development within a collaborative and mission-driven culture. We are proud to be an Equal Opportunity Employer, committed to creating an inclusive work environment free from discrimination and harassment. All employment decisions are based on qualifications, merit, and business needs.