Associate Director of Regulatory Affairs

A company is looking for a Shockwave Associate Director, Regulatory Affairs. Key Responsibilities Manage and mentor direct reports while developing regulatory strategies and ensuring compliance with regulations Compile, prepare, review, and submit regulatory submissions to authorities in various geographies Interact with regulatory authorities and communicate application progress to internal stakeholders Required Qualifications, Training, and Education Advanced degree in a relevant field (e.g., life sciences, engineering, or regulatory affairs) Significant experience in regulatory affairs, particularly in medical devices or pharmaceuticals Proven leadership experience in managing teams and projects Thorough understanding of applicable regulations and standards (e.g., ISO, 21 CFR) Experience in preparing and negotiating regulatory submissions and communications