Senior Regulatory Affairs Specialist - Onsite

Senior Regulatory Affairs Specialist supporting Medtronic's Neurovascular business in Irvine, California. This onsite role manages regulatory data governance, standards assessments, and digital transformation initiatives across multiple product portfolios to ensure global compliance and data integrity.

Responsibilities

• Serve as regulatory data subject-matter expert for Neurovascular portfolio governance and business processes
• Manage data quality reviews, discrepancy resolution, remediation, and continuous improvement initiatives
• Coordinate UDI activities and device registration data accuracy across labeling and cross-functional teams
• Lead standards gap assessments, including assignment tracking and stakeholder coordination
• Support regulatory systems implementation, testing, validation, and digital transformation initiatives

Requirements

• Bachelor's degree and 4+ years regulatory affairs, quality, standards, or medical device experience
• Advanced degree and 2+ years regulatory affairs, quality, standards, or medical device experience
• Project management experience across multiple stakeholders, products, or regulatory systems
• Experience coordinating standards assessments and driving completion with cross-functional teams
• Experience evaluating regulatory impacts and maintaining compliance documentation in regulated environments
• Knowledge of medical device regulatory frameworks and product lifecycle management