Strategic Director, Quality Systems & Regulatory Affairs

Alltrista Plastics LLC seeks a Director of Quality Systems and Regulatory Affairs to lead regulatory strategy and quality management across the organization. You will oversee the development, implementation, and maintenance of the QMS, coordinate submissions (FDA, PMA/510(k), CE), audits, and continuous improvement to drive product excellence. This role requires 10+ years in medical device QA/RA, strong leadership, and cross-functional collaboration with R&D, manufacturing, and marketing to