Sr. Manager Regulatory Affairs

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.

What You Will Do

• 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.

What You Will Need

Required Qualifications

• 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.

Preferred Qualifications

• 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.