Extremity Care
San Antonio, TX, USA
Purpose: The Vice President of Compliance and Regulatory Affairs will serve as an active member of the executive leadership team, is responsible for compliance with regulatory and legal requirements, and is responsible for development, execution of and supervision of regulatory strategies that support organizational objectives and operations that are compliant with FDA regulations, state requirements, ISO Standards, AATB Standards, and other applicable regulations. Duties & Responsibilities: Define and execute regulatory strategies and solutions in support of company strategic objectives Hold final accountability for decision-making on the matters relating to regulatory compliance for the organization. Plan and oversee (or execute) all FDA, state, and other regulatory/compliance activities Oversee regulatory submissions for TRG letters, Request for Designation (RFD), Pre-RFD, premarket notification/approvals, 510K, unique device identifiers (UDI), state licenses, etc....