Director of Regulatory Affairs

Job Summary

A company is looking for a Director of Regulatory Affairs to provide strategic counsel on regulatory and quality matters related to medical devices and digital health technologies.

Key Responsibilities

• Lead and provide guidance on regulatory product assessments and deliverables
• Prepare regulatory plans and support various regulatory, quality, and compliance activities
• Collect and analyze regulatory intelligence on evolving requirements and guidelines

Required Qualifications

• 10+ years of experience in medical device regulatory affairs or related field
• Direct experience with Software as a Medical Device (SaMD) and digital health products
• Proven experience in preparing regulatory documentation for FDA, EU MDR, and global agencies
• Familiarity with electronic quality management systems and applicable regulations
• Ability to manage multiple regulatory projects and priorities effectively