Principal Specialist, International RA

Work Flexibility: Remote or Hybrid or Onsite

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.

Travel Percentage: 0%

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.