The Regulatory Affairs Specialist will provide international and domestic regulatory affairs support for Medtronic Structural Heart medical devices. This position reports to the Regulatory Affairs Manager.
Specialize in Class II and III SHD products
Write and coordinate regulatory submissions for both developed and emerging countries/regions, including original IDE, original PMA, and 510(k) submissions and supplements, EU Design Dossiers and Technical Files, Canadian Device License Applications, Japanese Shonins, etc.
Manage the product dossiers and technical files for Medtronic SHD products
Provide regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis
Provide regulatory input to the company for compliance with EU and US FDA Quality System Regulation (QSR) requirements
Provide regulatory affairs input for clinical studies to assure compliance with all regulatory requirements (GCP, Declaration of Helsinki)
Review product labeling to assure compliance with regulatory requirements
Perform regulatory responsibilities independently with a minimal level of guidance and supervision
BA and/or BS degree
Minimum of 1 year regulatory affairs or other relevant experience.
Medtronic, Inc. is engaged in medical technology. The Company functions in seven operating segments that manufacture and sell device-based...