About this role
Director, Global Regulatory Affairs & Intelligence at Ekohealth. Location: Emeryville, California, United States. Role: leading strategy, driving submissions, managing interactions Requirements: Bachelor's in STEM,10+ years regulatory experience with Class II devices and SaMD, hands-on submission authorship, expertise in FDA/EU/ISO standards, regulatory intelligence, team leadership, and proficiency with regulatory platforms. Category: Legal and Compliance Seniority: Senior Level Tools: Veeva Vault, MasterControl, Greenlight Guru, eSTAR, EUDAMED Certifications: regulatory affairs (rac) Commitment: Full Time Workplace: Hybrid Languages: English