Nihon Kohden America is hiring a Vice President to lead Quality Assurance, Regulatory Affairs, Compliance, and Quality Systems for its medical device products, overseeing the Quality Management System, regulatory submissions, audits, and post-market activities. The role requires extensive FDA, ISO 13485, and Health Canada regulatory experience and proven leadership in a multinational medical device organization.
What you’ll do
Lead strategy and execution of Quality Assurance, Regulatory Affairs, Compliance, and Quality Systems activities
Oversee the Quality Management System
Manage regulatory submissions and interactions
Direct audits and post-market activities
Provide cross-functional support for medical device products
What you’ll need
15+ years of progressive QA/RA experience in the medical device industry
10+ years of people management experience
Demonstrated success leading FDA inspections and ISO 13485 surveillance/recertification audits
Extensive knowledge of FDA regulations, FDA QSR (21 CFR Part 820), ISO 13485, and Health Canada Medical Device Regulations
Strong experience with complaint handling, CAPA, post-market surveillance, MDR, recalls, field actions, supplier quality, and risk management
Executive leadership, strategic planning, and ability to balance regulatory compliance with commercial business objectives
Original job description
Nihon Kohden America seeks a Vice President to lead the strategy and execution of its Quality Assurance, Regulatory Affairs, Compliance, and Quality Systems activities. The role oversees the Quality Management System, regulatory submissions and interactions, audits, post-market activities, and cross-functional support for medical device products.…