Vice President, Regulatory Strategy and Innovation

📋 Description

• Define and execute the long-term regulatory strategy aligned with growth.
• Architect regulatory infrastructure for AI-enabled medical tech.
• Drive enterprise planning, portfolio prioritization, and global expansion.
• Position Regulatory Affairs as a strategic enabler of innovation and compliance.
• Lead RIM/eQMS modernization and AI-enabled regulatory intelligence.
• Advise executives on regulatory risk and market access.

🎯 Requirements

• B.S. or higher in Life Science or Engineering; JD preferred; RAC highly preferred.
• 15+ years in Regulatory Affairs with SaMD and AI/ML medical tech.
• 7–10 years of leadership, managing managers and multi-level teams.
• Experience with EU MDR, GCC markets; global regulatory strategy.
• SDLC, Agile; IEC 62304 and ISO 14971 in product development.
• RIM, eQMS, or digital regulatory infrastructure experience.
• Executive engagement with global regulatory authorities.
• Travel willingness up to 40%.

🎁 Benefits

• Remote-friendly with occasional travel for meetings.
• Competitive compensation and benefits.
• Equal opportunity employer.
• Access to offices in Denver, NY, Dallas, Lisbon (hybrid options).