Head of Regulatory Affairs

VirtualVocations
El Cajon, California, United States
Full-time

A company is looking for a Head of Regulatory Affairs to lead regulatory strategy and operations for AI-driven medical technologies.

Key ResponsibilitiesDevelop and implement regulatory strategies for compliance with FDA, MDR, and global requirementsLead regulatory submissions and interactions with regulatory bodiesCollaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycleRequired QualificationsBachelor's degree in a relevant field;

advanced degree preferredMinimum of 10 years of regulatory affairs experience in the medical device industryProven track record of successful regulatory submissions for AI-driven medical technologiesIn-depth knowledge of AI and its regulatory implicationsCertification in regulatory affairs (e.g., RAC) is highly desirable

8 days ago
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