Director, Business Development Quality Assurance - Remote

The Director, Business Development Quality Assurance (QA) is responsible for strategic and tactical functional support for business development projects. This role will be a key partner to the global BD team, ensuring that the function’s perspective is embedded in diligence and integration efforts. Responsibilities include providing in-depth analysis of Medical Device/Healthcare quality management system functionality, developing and executing a QA M&A readiness plan, and ensuring all regulatory documentation is maintained and ready for audits.

Bachelor’s degree in a science-related discipline; Master's preferred. Minimum of 15 years of directly related Regulatory Affairs experience; preferably a minimum of 10 years in a global role. Knowledge of and experience managing a Quality Management System and leading external QMS certification/surveillance audits. Thorough understanding of global submission requirements and appropriate design control requirements to satisfy global Health Authority submission standards.