About this role
Principal Regulatory Affairs Specialist at Elucent Medical. Location: Eden Prairie, Minnesota, United States. Role: preparing submissions, assessing changes, supporting compliance Requirements: Bachelor's in science or engineering required; 7+ years medical device regulatory affairs experience (or 5+ with advanced degree); hands-on FDA 510(k) experience, FDA interactions, regulatory assessments, and technical writing; RAC preferred. Category: Legal and Compliance Seniority: Senior Level Tools: 21 CFR Part 807, 21 CFR Part 801, 21 CFR Part 820, 21 CFR Part 830, QMSR, ISO 13485, ISO 14971, IEC 6