Global Regulatory Strategy Director

Job Summary

A company is looking for an AVP, Global Regulatory Strategy.

Key Responsibilities

• Develop and implement global regulatory strategies for product launches and lifecycle management
• Lead preparation and submission of regulatory dossiers for various international filings
• Serve as the primary liaison with regulatory authorities and provide guidance to cross-functional teams

Required Qualifications

• 10+ years of experience in regulatory affairs for medical devices, with 5+ years in Software as a Medical Device (SaMD)
• Experience leading global submissions, including FDA clearances and CE marking
• Hands-on experience with ISO 13485-compliant quality management systems for SaMD products
• Strong knowledge of FDA regulations, IEC standards, and cybersecurity guidelines
• Experience preparing regulatory submissions for AI/ML-enabled medical devices