Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)

Staff Regulatory Affairs Specialist role supporting Stryker's robotics and enabling technologies portfolio. Provides regulatory leadership across the product lifecycle, managing global submissions, compliance activities, and cross-functional partnerships for U.S. and international markets. Remote position.

Responsibilities

• Develop and execute global regulatory strategies for new products and lifecycle management activities
• Prepare and submit FDA and international regulatory filings with supporting documentation
• Evaluate product classifications, pathways, and jurisdictional requirements across markets
• Lead interactions with regulatory authorities and notified bodies on submissions and communications
• Review labeling, marketing materials, and clinical documentation for regulatory compliance

Requirements

• Bachelor's degree in Engineering, Sciences, Regulatory Affairs, or related field
• Minimum 4 years experience in FDA-regulated industry
• Minimum 3 years regulatory affairs experience
• Experience preparing regulatory submissions for product approvals
• Regulatory Affairs Certification (RAC) preferred
• Experience with Class II or III medical devices preferred

Compensation: $77,700-$207,400 USD Annual (varies by U.S. location/pay band)