Senior Global Regulatory Intelligence Lead

Edwards Lifesciences; Irvine (CA); On-site; USD 145,000 - 205,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Manager for Regulatory Intelligence & Corporate Regulatory Affairs to lead global regulatory initiatives and strategic compliance efforts. You will translate complex requirements into practical plans and collaborate across units to ensure timely market access for life-saving products.

The role demands extensive regulatory experience, executive communication, and the ability to influence stakeholders without direct authority, with

Qualifications

• Bachelor's or Master's degree in a relevant field with extensive regulatory experience.
• Experience independently leading complex cross-functional regulatory initiatives.

Responsibilities

• Serve as a subject matter expert on global regulatory intelligence and change management.
• Identify risks, gaps, and opportunities; lead enterprise-level regulatory initiatives and processes.
• Anticipate regulatory changes and assess impact to products, processes, and quality systems.
• Provide strategic direction for Regulatory Intelligence to enable early identification of changes.
• Translate complex regulatory requirements into actionable compliance plans and contingencies.
• Influence senior stakeholders across functions to resolve issues and drive timely execution.
• Lead stakeholder meetings with cross-functional and international partners, ensuring clear decisions.
• Represent Corporate Regulatory Affairs in governance forums with regulatory options and recommendations.
• Own regulatory operations such as FDA device listings, registrations, and CA manufacturing licenses.
• Provide technical leadership and knowledge transfer without direct people-management duties.
• Operate independently and escalate material risks as appropriate.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory intelligence

Stakeholder influence

Executive communication

Problem solving

Education

Bachelor's degree in science/engineering

Master's degree in regulatory affairs (preferred)

Tools

Regulatory systems

Data tools

Job description

Edwards Lifesciences in Irvine, CA is seeking a Senior Manager for Regulatory Intelligence & Corporate Regulatory Affairs to lead global regulatory initiatives and strategic compliance efforts. You will translate complex requirements into practical plans and collaborate across units to ensure timely market access for life-saving products.

The role demands extensive regulatory experience, executive communication, and the ability to influence stakeholders without direct authority, with