The Regulatory Affairs Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. Will provide subject matter expertise and is responsible for advising and guiding the local organization on regulatory topics. Will also be the primary liaison to Marketing and Sales groups with regard to regulatory requirements for marketing communications and other customer-facing communications. These activities will all be done in full compliance with U.S. and international regulatory requirements.
Monitor FDA’s databases for product MDR reportings, provide feedback to engineering
EDUCATION and/or EXPERIENCE: