Quality & Regulatory Director

Our client, XVIVO, is seeking a Quality & Regulatory Director to lead their US quality and regulatory activities and ensure compliance across the full product lifecycle. Founded in 1998 in Sweden, XVIVO is a global medical technology company dedicated to extending the life of all major organs, enabling transplant teams to save more lives. Through its advanced perfusion technologies and innovative solutions, XVIVO empowers leading clinicians and researchers to push the boundaries of what is possible in transplantation.

Their systems are designed not only to improve transplant outcomes but also to streamline surgical teams' workflows and enhance patients' long-term quality of life. XVIVO's mission is simple but powerful: no one should die waiting for an organ.

Joining XVIVO means becoming part of a purpose-driven organization where your work directly contributes to life-saving advancements and meaningful impact on a global scale.

As Quality & Regulatory Director, you will lead XVIVO's quality and regulatory function and ensure products, processes, and activities meet applicable regulatory and quality requirements. This critical leadership role requires someone who can balance strategic oversight with hands-on execution in a highly regulated medical environment. As a people leader, you will manage and develop the Quality and Regulatory team while remaining actively involved in day-to-day operational quality and regulatory activities.

You will oversee regulatory activities for the US market, support compliance across the product lifecycle, and provide quality and regulatory guidance to cross-functional teams involved in product development, clinical activities, manufacturing, commercialization, labeling, post-approval changes, and ongoing compliance. This role requires a strong understanding of regulatory submissions, quality management systems, safety reporting, and collaboration with regulatory authorities. This role is based at XVIVO's North American HQ in Golden, CO, and reports directly to the Chief Operating Officer.

Occasional travel is to be expected.

Your responsibilities include:

• Lead and oversee quality and regulatory activities globally
• Drive the preparation, review, and submission of regulatory filings for all markets where XVIVO is present
• Provide strategic regulatory guidance throughout the product lifecycle, including clinical development, design updates, labeling, and post-approval changes
• Lead, coach, and develop the global quality and regulatory team while maintaining active involvement in operational activities
• Ensure product labeling, IFUs, marketing claims, and promotional materials are accurate, compliant, and aligned with applicable requirements
• Oversee adherence to the quality management system and applicable SOPs
• Lead safety reporting and compliance activities in accordance with applicable regulations
• Identify, interpret, and communicate regulatory and quality requirements to support continued product and legal compliance
• Partner closely with R&D, Clinical, Quality, Manufacturing, and Commercial teams to integrate regulatory and quality requirements into development and go-to-market strategies
• Serve as a key point of contact with regulatory authorities on behalf of XVIVO
• Support a culture of quality, accountability, and continuous improvement across the organization

• Min. 7 years of experience in quality and/or regulatory roles within the medical device industry
• Previous experience leading or managing quality and regulatory activities in a regulated environment
• Experience working with and communicating directly with regulatory authorities
• Strong knowledge of regulatory submissions and US medical device regulatory pathways, including IDEs, PMAs, and 510(k) s
• Experience supporting regulatory compliance across product development, clinical activities, labeling, commercialization, and post-approval changes
• Strong knowledge of medical device quality system standards and regulations, including MDSAP, ISO 13485, QMSR, and applicable FDA regulations
• Solid understanding of quality management systems, SOPs, safety…