Responsibilities:
The Regulatory Affairs Specialist is responsible for working with cross-functional teams to bring IVD (In-Vitro Diagnostic), Research (RUO) and Laboratorial products to market and support activities related to Quality Management System (QMS) to ensure ongoing compliance while continuing to develop regulatory affairs skills
This position reports to the Director, Quality Assurance and Regulatory Compliance (Management Representative) and is part of the Regulatory Compliance team located in Richmond, Illinois and will be onsite
Support product registrations, listings, and renewals globally with the support of Leica partners, and directly in US, Canada, and EU markets, requiring cross-functional and cross-site partnership and execution for new products and change management
Support new product development, design change, and sustainment projects by reviewing and approving design files connected to regulator...