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
Requirements:
- 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
Benefits:
- 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.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1