Senior Regulatory Affairs Lead – Medical Devices

Stryker; Irvine (CA); Hybrid; USD 167,000 - 279,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Life and AD&D insurance

Short-term disability

Job summary

Stryker is seeking a Senior Manager, Regulatory Affairs for its Peripheral Vascular division in Irvine, CA. This hybrid role combines strategic regulatory leadership with hands-on guidance across the product lifecycle to ensure U.S.

and international compliance, while enabling innovation and growth. The candidate will lead a high-performing Regulatory Affairs team, drive submissions and regulatory changes, and collaborate with cross-functional partners to integrate regulatory requirements into

Qualifications

• Minimum 10+ years of experience within regulated environments with regulatory interpretation across the product lifecycle.
• Minimum 3 years of demonstrated people leadership, talent development, performance management, and team engagement.
• Experience analyzing regulatory data, trends, and performance metrics to support compliance and risk management.

Responsibilities

• Support global regulatory strategy across full product lifecycle, including development, post-market changes, and obsolescence.
• Provide regulatory guidance on claims, labeling, IFUs, patient materials to ensure regulatory compliance.
• Assess product changes and determine regulatory impact, requirements, and submissions.
• Monitor evolving regulatory requirements and their impact on products and business operations.
• Partner cross-functional to integrate regulatory requirements into development, quality, clinical, and business objectives.
• Lead regulatory operations: project management, timelines, metrics, reporting, processes, audits, and authority interactions.
• Develop and deliver regulatory training; improve regulatory systems and compliance.
• Build and lead a high-performing Regulatory Affairs team with budgeting and forecasting.

Skills

Regulatory strategy

Regulatory submissions

People leadership

Project management

Cross-functional collaboration

Training programs

Budgeting & forecasting

Regulatory compliance

Education

Bachelor's degree

Bachelor's degree or higher in Science/Engineering

Job description

Stryker is seeking a Senior Manager, Regulatory Affairs for its Peripheral Vascular division in Irvine, CA. This hybrid role combines strategic regulatory leadership with hands-on guidance across the product lifecycle to ensure U.S.

and international compliance, while enabling innovation and growth. The candidate will lead a high-performing Regulatory Affairs team, drive submissions and regulatory changes, and collaborate with cross-functional partners to integrate regulatory requirements into