Associate Director of Regulatory Affairs

Job Summary

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