Principal Specialist, International RA

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: 01/20/2026
This role will be posted for a minimum of 3 days.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.