Senior Manager, Regulatory Affairs

Work Flexibility: HybridStryker 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 doSupport 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 needRequired Qualifications: Bachelor’s degreeMinimum 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 disciplineExperience 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 AnnualTravel 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.SummaryLocation: Irvine, CaliforniaType: Full time