Senior Manager, Regulatory Affairs

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 Strykers 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:

• Bachelors 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: $167200 - $278600 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 contractors legal duty to furnish information.