Senior Regulatory Affairs Specialist - Onsite

A Day in the Life

The Neurovascular business within Medtronic develops technologies that support the treatment of stroke and other neurovascular conditions. The Regulatory Affairs organization partners across product development, quality, labeling, clinical, and commercial functions to ensure global regulatory compliance and product availability. This role supports regulatory data governance, regulatory process ownership, standards assessments, digital transformation initiatives, and cross-portfolio projects that impact multiple products and regulatory systems across the Neurovascular portfolio.

This position is based in Irvine, California, and follows an onsite work model. No travel is required.

The Senior Regulatory Affairs Specialist serves as a regulatory subject-matter expert supporting regulatory data integrity, regulatory process excellence, standards assessments, and the implementation of regulatory systems and digital solutions. This role works across multiple product portfolios and regulatory functions to improve data quality, support regulatory initiatives, coordinate cross-functional assessments, and ensure regulatory information is maintained accurately across business systems.

Primary Responsibilities

• Serve as a subject matter expert for regulatory data, related business processes, and regulatory systems across the Neurovascular portfolio.
• Manage regulatory data governance activities, including data quality reviews, discrepancy resolution, remediation efforts, and continuous improvement initiatives.
• Coordinate Unique Device Identification (UDI) activities and partner with Regulatory Affairs, Labeling, and cross-functional teams to maintain accurate device registration data.
• Lead standards gap assessment processes, including assignment, tracking, documentation, stakeholder coordination, and completion of required actions.
• Coordinate regulatory change assessments and evaluate potential impacts across products, regions, registrations, and regulatory systems.
• Lead or support cross-functional regulatory projects involving multiple products, product families, or regulatory teams.
• Support implementation, testing, validation, migration, reconciliation, and verification activities for regulatory systems and digital solutions.
• Partner with business and corporate stakeholders to implement process improvements, automation opportunities, and AI-enabled regulatory initiatives.

Required Qualifications

• Bachelor's degree and 4+ years of regulatory affairs, quality, standards, or medical device experience OR Advanced degree and 2+ years of regulatory affairs, quality, standards, or medical device experience.
• Experience managing projects, processes, or initiatives involving multiple stakeholders, products, or regulatory systems.
• Experience coordinating standards assessments and driving actions to completion with Regulatory Affairs and cross-functional subject matter experts.
• Experience evaluating regulatory impacts and maintaining compliance-related documentation, data, or business processes.
• Experience working within regulated medical device environments.

Preferred Qualifications

• Experience with Unique Device Identification (UDI), global device registrations, EUDAMED, regulatory information management systems, or data governance.
• Experience supporting digital transformation, automation, analytics, or AI-enabled initiatives in a regulated environment.
• Experience assessing the regulatory impact of standards updates across product portfolios and supporting related change assessments.
• Experience leading cross-functional projects involving regulatory systems, process improvements, or enterprise initiatives.
• Knowledge of global medical device regulatory requirements, registrations, and product lifecycle management processes.