Global Regulatory Strategy Director

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

Created: 2026-03-05