Global Head of Quality & Regulatory Strategy

EPM Scientific collaborates with a rapidly growing structural heart medical device company to seek a Vice President of Quality. The role will lead the Quality organization through commercialization and global expansion from Boston, MA, on-site. The executive will set the Quality vision and strategy, oversee the QMS, and ensure compliance with FDA, ISO 13485, MDR, and MDSAP across development, manufacturing, supplier management, and post-market activities.