Senior Director Regulatory Intelligence

Job Summary

Leading the establishment of a world-class regulatory intelligence capability, the full-time Senior Director Regulatory Intelligence will work remotely to proactively identify and implement global regulatory requirements and trends across various product categories while partnering with cross-functional teams to ensure compliance and strategic alignment.

Key responsibilities

• Develop and execute the global regulatory intelligence strategy, including impact assessments for significant regulatory changes
• Serve as an enterprise expert in regulatory response strategies, leading the preparation of responses to FDA observations and enforcement actions
• Identify emerging regulatory trends and prepare dashboards summarizing regulatory changes, compliance risks, and strategic opportunities

Required qualifications

• Bachelor's degree in Regulatory Affairs, biology, biomedical engineering, or related field
• 10+ years of progressive Regulatory Affairs and/or Quality leadership experience
• 8+ years of direct interaction with global health authorities
• Significant experience in highly regulated healthcare industries, including Medical Devices and Pharmaceuticals
• Direct authorship of multiple FDA-483 and Warning Letter responses