Senior Manager, Regulatory Affairs

Stryker Corporation; Irvine (CA); On-site; Confidential; Full time

Job summary

Stryker Corporation in Irvine, CA, is hiring a Senior Manager, Regulatory Affairs for the Peripheral Vascular division. Hybrid role; in-office 3 days/week with remote work the rest.

You will lead global regulatory strategy, ensure compliance across the product lifecycle, and guide labeling, claims, and IFUs while driving cross-functional collaboration. The role requires 10+ years in regulated environments, 3+ years in people leadership, and experience with FDA/EU regulatory activities.

Qualifications

• 10+ years in regulated environments with product lifecycle experience.
• 3+ years of people leadership and team management.
• Experience analyzing regulatory data and performance metrics.

Responsibilities

• Support global regulatory strategy across full product lifecycle, including changes and obsolescence.
• Provide regulatory guidance on labeling, IFUs and product information to ensure compliance.
• Assess regulatory impact of product changes, manufacturing, suppliers and clinical data.
• Monitor evolving regulatory requirements and their impact on operations.
• Lead regulatory operations: projects, timelines, metrics, audits, and authority interactions.
• Develop and deliver regulatory training and drive continuous improvement of systems.
• Build and lead a high-performing Regulatory Affairs team with budgeting and forecasting.

Skills

Regulatory strategy

People leadership

Regulatory submissions

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree

Science or Engineering degree

Job description

Work Flexibility: Hybrid 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 Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces!

For more information, visit: www.stryker.com

Work Flexibility

• Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.
• Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.
• Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.
• Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.