Senior Manager, Regulatory Affairs

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 hiring a Senior Manager, Regulatory Affairs for our Peripheral Vascular division in Irvine, CA. The Senior Manager, Regulatory Affairs is a strategic people leader responsible for driving global regulatory strategy and compliance across the full product lifecycle for Stryker's Peripheral Vascular portfolio. This role partners closely with cross-functional teams to ensure products meet U.S. and international regulatory requirements while supporting innovation, commercialization, and business growth. The Senior Manager leads regulatory operations, regulatory submissions and compliance activities, provides expert guidance on product changes and labeling, and develops a high-performing Regulatory Affairs team. This position plays a critical role in shaping regulatory strategy, influencing business decisions, and ensuring successful interactions with global regulatory authorities throughout the product lifecycle.

Workplace Flexibility:

This is a hybrid role requiring the candidate to be within commuting distance to Irvine, CA. The work schedule is structured to support flexibility, with in-office presence required 3 days/week and remote work available the rest of the week. To qualify, candidates must be able to commute to the facility as needed.

What You Will Do

• Support global regulatory strategy across the full product lifecycle, including development, post-market changes, and product obsolescence.
• Provide regulatory guidance on product claims, labeling, IFUs, patient materials, and other product information to ensure compliance and accuracy.
• Assess product, manufacturing, supplier, and clinical changes, determining regulatory impact, requirements, and submissions.
• Monitor evolving regulatory requirements and evaluate their impact on products, business operations, and strategic initiatives.
• Partner cross-functional to integrate regulatory requirements into product development, quality, clinical, and business objectives.
• Lead regulatory operations, including project management, timelines, metrics, reporting, processes, compliance programs, audits, inspections, and regulatory authority interactions.
• Develop and deliver regulatory training while driving continuous improvement of regulatory systems, procedures, and organizational compliance.
• Build, lead, and engage a high-performing Regulatory Affairs team through talent development, performance management, resource planning, budgeting, and forecasting.

What You Need

Required Qualifications

• Bachelor's degree
• Minimum 10+ years of experience within regulated environments, with expertise in interpreting and applying international regulatory requirements throughout the product lifecycle.
• Minimum 3 years of demonstrated experience in people leadership, including talent development, performance management, and team engagement.
• Experience analyzing regulatory data, trends, and performance metrics to support compliance, risk management, and business decision-making.

Preferred Qualifications

• Bachelor degree or higher in a Science or Engineering related discipline
• Experience working within the medical device industry, including knowledge of FDA regulations and quality requirements.
• Experience supporting regulatory submissions, including FDA 510(k) and/or EU MDR requirements.
• Demonstrated project management experience, including planning, execution, timeline management, and cross-functional coordination.

US15: $167,200 - $278,600 USD Annual

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.