Manager, Quality & Regulatory Compliance

Maintain and improve the Quality Management System in compliance with ISO 13485 and applicable regulations, managing document control, SOPs, training, and quality records. Coordinate internal and external audits, monitor quality metrics, and lead CAPA processes including root cause investigations. Oversee supplier qualification, audits, and performance monitoring while managing complaint investigations and adverse event reporting. Maintain product risk management documentation throughout the lifecycle and support design control, verification, validation, and change management activities. Develop regulatory strategies for product registrations, submissions, and approvals across global markets, including CE Marking. Support regulatory inspections and drive operational quality improvements such as process validation and calibration. This role partners cross-functionally to support product development and post-market activities within a high-performance culture where colleagues embrace challenges and drive transformative solutions.