Regulatory Affairs Manager

Job Summary

A company is looking for a Manager/Senior Manager, Regulatory Affairs - CDx.

Key Responsibilities

• Develop and lead global regulatory strategies to support business objectives
• Lead submissions and correspondence with global regulatory authorities including various authorizations
• Establish processes for addressing multiple regulatory frameworks efficiently

Required Qualifications and Education

• Bachelor's degree in a scientific discipline; MS, MSE, or PhD preferred
• Minimum of 5+ years of experience in Regulatory Affairs related to medical devices
• Experience with complex medical devices, including software and AI-based devices
• Knowledge of regulatory submissions such as PMA, 510(k), and IDE requirements
• Strong project management skills with the ability to execute in a fast-paced environment