About the role
Join
the team leading the next evolution of virtual care. At Teladoc Health, you are empowered to bring your true self to work while helping millions of people live their healthiest lives. Here you will be part of a high-performance culture where colleagues embrace challenges, drive transformative solutions, and create opportunities for growth. Together, we’re transforming how better health happens. Summary of Position The Manager, Quality & Regulatory Compliance oversees the Quality Management System (QMS) and ensures compliance with applicable quality and regulatory
requirements. This role partners cross-functionally to support ISO 13485 compliance, audits, supplier quality, CAPA, risk management, product development, post-market activities, and regulatory submissions. Essential Duties and
Responsibilities Quality Systems & Compliance Maintain and improve the QMS in compliance with ISO 13485 and applicable regulations. Manage document control, SOPs, training, quality records, and management reviews. Coordinate internal, external, and certification audits. Monitor quality metrics and drive continuous improvement initiatives. Lead CAPA processes, root cause investigations, and corrective actions. Supplier Quality Manage supplier qualification, audits, and Approved Supplier List activities. Support supplier performance monitoring, investigations, and corrective actions. Review supplier changes and assess quality and regulatory impact. Complaint Handling & Post-Market Surveillance Oversee complaint investigations, trending, adverse event reporting, and post-market surveillance activities. Identify quality signals and ensure appropriate escalation and risk management actions. Risk Management & Product Development Maintain product risk management documentation throughout the product lifecycle. Support design control, product development, verification, validation, and change management activities. Ensure quality and regulatory
requirements are integrated into development processes. Regulatory Affairs Develop regulatory strategies and support product registrations, submissions, approvals, and licenses. Maintain technical documentation and regulatory compliance in global markets, including CE Marking activities. Review product labeling, marketing materials, and promotional claims for compliance. Audits & Operational Quality Support regulatory inspections, product audits, and ISO 13485 certification audits. Drive operational quality improvements, nonconformance investigations, process validation, inspections, calibration, and training activities.