Manager Regulatory Affairs - (Gainesville, FL)

Responsibilities: 1. Directing the work of others in preparing and maintaining FDA pre-market submissions, Canadian device license applications and international product registrations for medical devices. Directing the work of others in creating, compiling and maintaining technical file and design dossier documentation to support CE marking of products for the European Union. 2. Lead or participate in Regulatory and QMS audits (internal or external) to achieve successful audit outcomes. 3. Manage post market regulatory compliance activities (i.e., complaint handling, correction and removal processes). 4. Preparing and maintaining FDA pre-market submissions, Canadian device license applications and international product registrations for medical devices. 5. Preparing and submitting MDD Class III Design Dossiers for review by the Notified Body. 6. Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification. 7.