Regulatory Data & Systems Lead — Neurovascular

Regulatory Jobs; Irvine (CA); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

401(k) with match

Paid time off

Tuition assistance

Job summary

Medtronic’s Neurovascular Regulatory Affairs team in Irvine, CA, seeks a Senior Regulatory Affairs Specialist to support regulatory data governance, processes, and systems. This onsite role collaborates across product development, quality, labeling, clinical, and commercial functions to ensure global regulatory compliance and data integrity.

Responsibilities include governance, standard assessments, UDI coordination, and cross-functional project leadership, with opportunities to leverage

Qualifications

• Bachelor's degree with 4+ years in regulatory affairs, quality, standards, or medical device experience (or advanced degree with 2+ years).
• Experience coordinating standards assessments with Regulatory Affairs and cross-functional subject matter experts.
• Experience evaluating regulatory impacts and maintaining compliance documentation.
• Experience working in regulated medical device environments.

Responsibilities

• Serve as a subject matter expert for regulatory data and regulatory systems across the Neurovascular portfolio.
• Manage regulatory data governance activities, including data quality reviews and remediation efforts.
• Coordinate Unique Device Identification (UDI) activities and maintain device registration data.
• Lead standards gap assessment processes and track actions to completion.
• Coordinate regulatory change assessments across products, regions, and systems.
• Lead or support cross-functional regulatory projects involving multiple products or teams.
• Support implementation, testing, validation, migration, and verification of regulatory systems and digital solutions.
• Partner with stakeholders to implement process improvements, automation opportunities, and AI-enabled regulatory initiatives.

Skills

Regulatory data governance

Project management

Cross-functional collaboration

Data integrity

Education

Bachelor's degree or higher in life sciences or related field

Advanced degree in related field

Tools

Regulatory information management systems

Job description

Medtronic’s Neurovascular Regulatory Affairs team in Irvine, CA, seeks a Senior Regulatory Affairs Specialist to support regulatory data governance, processes, and systems. This onsite role collaborates across product development, quality, labeling, clinical, and commercial functions to ensure global regulatory compliance and data integrity.

Responsibilities include governance, standard assessments, UDI coordination, and cross-functional project leadership, with opportunities to leverage