Quality & Compliance Manager
Core
Ensure adherence to regulatory standards, ethical guidelines, and internal policies for a multi-specialty medical institution.
Role type
Quality & Compliance Manager
Builds
Compliance programs, quality management systems, and risk mitigation strategies for medical devices and clinical trials.
Domain
Healthcare / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory compliance monitoring, internal audit execution, quality management system implementation, risk assessment, data privacy management, training program development, SOP management
Preferred skills
Master's degree in Law, Business, or Healthcare Administration, Certified in Healthcare Compliance
Technologies
ISO 13485, NDPR
Responsibilities
Monitor regulatory changes (FDA, ISO), conduct internal audits, oversee regulatory approval for new products/devices/trials, manage supplier quality, develop recall procedures, implement data breach response plans, conduct risk assessments, deliver compliance training.
Seniority
Mid-Senior, hands-on IC