Principal Specialist, International RA

Stryker•San Jose, CA

9d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.