Description
The Quality Systems and Regulatory Compliance Representative will independently manage quality processes across the commercial product lifecycle for the Korea Affiliate, including the Quality Management System, regulatory compliance, distribution and 3PL quality oversight, capital equipment and service quality, post-market quality, and continuous improvement. The role partners with global, APAC, and local stakeholders to mitigate quality and regulatory risks, support inspections and audits, and maintain compliance with Boston Scientific quality requirements, Korean medical device regulations, and KGMP expectations. A bachelor's degree in a relevant discipline and at least seven years of quality system management experience in a regulated industry are required.
