Director of Quality & Regulatory

Isto Biologics, a 100% biologics-focused company dedicated to helping patients heal faster, is seeking a Director of Quality & Regulatory in their Carlsbad, CA facility. With a portfolio comprised of the market-leading autologous concentration device as well as a differentiated bone grafting portfolio that offers functional solutions to meet patient and procedural challenges, Isto is equipped to offer a range of customizable options to surgeons of varying specialties.

The Director of Quality & Regulatory is responsible for leading and overseeing all quality assurance and regulatory compliance activities for the Company’s AATB-accredited tissue bank. This individual serves as the head of the Quality & Regulatory function and is accountable for maintaining compliance with AATB Standards, FDA 21 CFR Part 1271, applicable state regulations, and other relevant requirements.

This role is both strategic and hands-on in nature, reflecting the needs of a small, growing organization. The Director provides leadership and direction while remaining actively involved in key quality and regulatory activities, and manages a team of approximately six professionals. The position serves as the primary point of contact with regulatory authorities and accreditation bodies and has final authority over quality and regulatory matters, working in close partnership with the General Manager and other senior leaders.

• Provide overall leadership and direction for the Quality & Regulatory department, ensuring sustained compliance with AATB Standards, FDA regulations (21 CFR Part 1271), and applicable federal, state, and local requirements.
• Maintain final decision-making authority on quality and regulatory matters, including product disposition, investigations, and compliance actions, while collaborating closely with the General Manager and cross-functional leadership.
• Establish, maintain, and continuously improve the Quality Management System to support compliant and efficient tissue banking operations.
• Identify, assess, and prioritize quality and compliance risks, ensuring appropriate actions are implemented and monitored.
• Oversee and actively participate in internal audits, inspection readiness activities, and compliance monitoring programs.
• Serve as the primary Company contact for FDA, AATB, state regulators, and other external auditors or inspectors, including leading inspection preparation, hosting inspections, and overseeing responses and follow-up activities.
• Provide oversight and hands‑on involvement in quality investigations, nonconformances, CAPA, recalls, and field actions, ensuring timely, effective, and well‑documented resolution.
• Ensure appropriate oversight and qualification of tissue recovery agencies, suppliers, and other tissue bank partners.
• Provide quality and regulatory guidance for new and existing products, process changes, and business initiatives.
• Ensure company policies, procedures, and records remain current, effective, and aligned with regulatory and accreditation requirements.
• Plan, prepare, and lead management reviews of the Quality Management System, ensuring appropriate inputs, outputs, documentation, and follow‑up actions are completed.
• Monitor and report quality and compliance metrics to management, supporting informed decision‑making.
• Lead, mentor, and develop Quality & Regulatory staff, balancing delegation with direct involvement, as needed.
• Work collaboratively with Operations and other departments to integrate quality and compliance into daily activities and continuous improvement efforts.

• · Bachelor’s degree in science or a related field required; advanced degree preferred.
• Minimum of 10 years of progressive experience in quality and/or regulatory roles within a regulated tissue banking, HCT/P, or biologics environment.
• Demonstrated experience working within an AATB‑accredited tissue bank, including direct knowledge of AATB Standards and FDA 21 CFR Part 1271.
• Experience serving as a lead or primary contact during FDA, AATB, or state inspections.
• Prior experience managing and developing quality and/or regulatory staff.
• Certified Tissue Bank Specialist (cTBS)…