Principal Specialist, International RA  

Locations: San Jose, CA / Flower Mound, TX / Denver, CO

At Stryker, regulatory excellence enables innovation that saves and improves lives. As a Principal Specialist in International Regulatory Affairs, you will shape global regulatory strategies that accelerate access to medical technologies while protecting patients and communities worldwide. This is a highly visible role where strategic thinking, global impact, and regulatory leadership come together.

Work Flexibility:

Hybrid – must reside within a commutable distance to one of the listed Stryker facilities and work onsite several times per week.

What You Will Do

• Develop and maintain global, regional, and multi‑country regulatory strategies aligned with business and product lifecycle objectives to achieve timely market access.
• Evaluate global regulatory trends, stakeholder expectations, and evolving requirements to inform long‑range regulatory planning and risk mitigation.
• Identify regulatory pathways for new and existing product designs; assess adequacy of proposed strategies and recommend refinements based on regulatory outcomes.
• Guide cross‑functional teams on regulatory considerations for product entry, exit, labeling, claims, and data requirements, ensuring submission readiness.
• Lead negotiations and sustained interactions with regulatory authorities across development, approval, and post‑approval phases to resolve complex issues.
• Assess regulatory impacts of clinical, preclinical, and manufacturing changes and determine submission or non‑submission approaches.
• Oversee preparation and approval of high‑quality electronic and paper regulatory submissions to achieve on‑time global filings.
• Prepare teams for regulatory inspections, audits, advisory panels, and authority meetings, supporting successful outcomes and renewals.

What You Will Need

Required

• Bachelor’s degree in Engineering, Science, or a related field.
• 8+ years of professional experience, including work in medical device regulatory affairs or a closely related field.

Preferred

• Master’s degree in Regulatory Science or related field.
• Regulatory Affairs Certification (RAC).
• Experience developing global, multi‑country regulatory strategies for devices addressing serious or life‑threatening conditions or unmet needs.

$126,500 - $273,900 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Posted Date: 01/12/2026
This role will be posted for a minimum of 3 days.