Senior Regulatory Affairs Specialist

POSITION SUMMARY: The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. PRIMARY RESPONSIBILITIES: Understands and interprets U.S. and EU and international medical device and in vitro diagnostic device (IVD) regulatory requirements. Provides guidance on requirements to product development teams. Develops strategies for submissions to FDA and other regulatory agencies. Provides risk assessments and regulatory options. Prepares U.S. regulatory submissions necessary for new product market clearance/approval and product continuance: 510(k)s; Pre-market Approval Applications (PMA) and supplements; Product Development Protocols (PDP); Investigational Device Exemptions (IDE); Pre-Submissions and supplements. Prepares and/or compiles information required by ex-U.S. regulatory associates to register or license products outside the U.S. Interacts and negotiates with U.S. regulatory agencies. Coordinates the preparation of additional data/information requested by regulatory agencies and prepares appropriate responses to all such requests. Participates in th