Senior Manager, Regulatory Affairs

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

Job summary

Stryker in Irvine, CA is seeking a Senior Manager, Regulatory Affairs to lead global regulatory strategy across the full product lifecycle for the Peripheral Vascular portfolio. The role requires collaboration with cross-functional teams to ensure compliance with US and international requirements while enabling innovation and growth.

Responsibilities include guiding labeling and product information, assessing regulatory impact of changes, and directing regulatory operations and training.

Qualifications

• Bachelor’s degree required.
• 10+ years in regulated environments with regulatory lifecycle experience.
• 3+ years of people leadership experience.
• Experience analyzing regulatory data, trends and metrics.

Responsibilities

• Support global regulatory strategy across the full product lifecycle.
• Provide regulatory guidance on labeling, IFUs, and patient materials.
• Assess regulatory impact of changes to products, manufacturing, suppliers, and clinical data.
• Monitor evolving regulatory requirements and their impact on business operations.
• Partner cross-functionally to integrate regulatory requirements into development and quality objectives.
• Lead regulatory operations: planning, timelines, audits, and inspections.
• Develop and deliver regulatory training and improve regulatory systems.

Skills

Regulatory strategy

People leadership

Regulatory compliance

Regulatory submissions

Education

Bachelor's degree

Science or Engineering degree (preferred)

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-functionally 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 and 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