Regulatory Affairs Director

Job Summary

A company is looking for a Regulatory Affairs Director.

Key Responsibilities

• Develop and implement global regulatory strategies aligned with business objectives
• Manage and develop a team of regulatory professionals, ensuring compliance with regulations
• Lead regulatory submissions and maintain technical documentation for product approvals

Required Qualifications

• Bachelor's degree in a relevant field or equivalent experience
• 15+ years of experience in a regulated industry, preferably with FDA and Software as a Medical Device
• Strong knowledge of FDA Quality System Regulations and experience with regulatory filings
• Experience with US FDA Class I and II medical devices, with additional experience in Class III devices preferred
• Knowledge of Medical Devices Regulations and related standards