Principal Specialist, International RA

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

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.

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.

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