Sr. Manager Regulatory Affairs

Work Flexibility:
Hybrid

Join Stryker’s Peripheral Vascular division in Irvine, CA
, where you’ll play a pivotal role in advancing life‑enhancing medical technologies. As a Senior Regulatory Affairs Manager
- International
, you will lead global regulatory strategies that accelerate patient access to innovative solutions and directly shape successful product launches across key international markets. This is an opportunity to make a measurable impact while developing a high‑performing team in a fast‑moving, mission‑driven environment.

• Lead day‑to‑day global regulatory operations, ensuring activities are accurately evaluated, prioritized, and executed to meet business timelines.
• Oversee preparation, review, and submission of regulatory filings supporting market access across EMEA
  , EU
  , APAC
  , and Latin America
  .
• Manage regulatory processes for Patient‑Specific Solutions, including compassionate use and special access pathways.
• Interpret global regulatory requirements and guide internal teams on submission strategies, labeling compliance, and product claims.
• Ensure regulatory submissions, labeling, and marketing materials meet all applicable standards and internal quality expectations.
• Represent Regulatory Affairs in internal and external audits with health authorities and Notified Bodies.
• Partner with Quality, R&D, Supply Chain, Finance, Sales, and Marketing to drive cross‑functional alignment on regulatory deliverables.
• Lead and develop a high‑performing Regulatory Affairs team, providing coaching, goal setting, issue resolution, and ongoing performance management.
• Establish standardized regulatory processes with clear ownership and implement practical process improvements to reduce inefficiencies.
• Track and report regulatory metrics, workload distribution, and submission timelines to support operational planning and budget management.

• Bachelor’s degree required. (Engineering, Science, or related field preferred).
• Minimum 10 years of experience in an FDA‑regulated industry.
• Minimum 3 years of people leadership experience.
• Medical device industry experience required.

• Master’s degree and/or Regulatory Affairs Certification (RAC).
• Experience with international submissions across EMEA, EU, APAC, Latin America, and Canada.
• Experience leading geographically dispersed teams.

$167,000-$278,600 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

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.