Vice President, Regulatory Strategy and Innovation
Job Description
Team: Legal
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Vice President, Regulatory Strategy and Innovation in United States.
This is a senior executive role shaping the future of regulatory strategy within a fast-scaling, AI-driven medical technology organization. You will define and lead the enterprise-wide regulatory vision, ensuring alignment with product innovation, global expansion, and commercial strategy. The role goes far beyond traditional compliance, positioning Regulatory Affairs as a strategic enabler of innovation and competitive differentiation. You will build scalable regulatory frameworks for AI-enabled medical software and next-generation diagnostic solutions. Operating at the executive level, you will influence enterprise decisions, risk posture, and international market access. This position requires a forward-thinking leader capable of translating complex global regulatory landscapes into actionable strategy and long-term growth infrastructure.
Accountabilities:
- Define and lead the enterprise regulatory strategy aligned with global growth, product innovation, and portfolio expansion priorities
- Architect scalable regulatory frameworks for AI/ML-enabled software, modular architectures, and evolving digital health solutions
- Drive global market access strategy, including U.S., EU MDR regions, EMEA, and GCC, ensuring harmonized submissions and regulatory alignment
- Establish governance models, policies, and standards to ensure consistent, compliant execution across the organization
- Oversee modernization of regulatory operations, including RIM systems, eQMS integration, and AI-powered regulatory intelligence capabilities
- Serve as executive liaison with global health authorities and represent the organization in strategic regulatory engagements
- Lead cross-functional alignment across Product, Engineering, Clinical, Legal, and Commercial teams to embed regulatory strategy into business execution
- Build and develop high-performing regulatory leadership teams, ensuring succession planning and organizational scalability
- 15+ years of progressive regulatory affairs experience, including leadership roles in SaMD and AI/ML-enabled medical technologies
- Strong background in Class II/III medical devices, ideally within cardiovascular or diagnostic imaging domains
- Experience defining global regulatory strategy under EU MDR and other international frameworks
- Demonstrated executive-level engagement with global regulatory authorities
- Strong understanding of software development lifecycle (SDLC), agile methodologies, and standards such as IEC 62304 and ISO 14971
- Experience implementing or modernizing regulatory systems such as RIM and eQMS platforms
- Proven ability to lead large, multi-level teams and influence cross-functional executive stakeholders
- Strong strategic thinking, business acumen, and ability to operate in complex, ambiguous environments
- Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree or JD preferred; RAC certification strongly preferred
- Approximately 40% travel required
- Competitive base salary ranging from $280,000 to $300,000 depending on location and experience
- Target annual bonus of 20%, bringing total target compensation to $336,000–$360,000
- Stock options as part of the total rewards package
- Comprehensive medical, dental, and vision insurance coverage
- 401(k) retirement savings plan
- Fully remote-first work model with flexibility across the United States
- Exposure to cutting-edge AI-driven healthcare innovation and global regulatory transformation
- Additional employee perks and long-term career growth opportunities within a high-impact organization.
Requirements:
Benefits:
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Date Posted
05/04/2026
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