Vice President of Regulatory Affairs

Overview

We are seeking an accomplished Vice President of Regulatory Affairs to lead the global regulatory vision, strategy, and execution for a diverse portfolio of medical devices. This executive leader will architect regulatory pathways, ensure worldwide compliance, and drive organizational excellence across all premarket and postmarket regulatory activities. The ideal candidate brings deep expertise in U.S. FDA regulatory frameworks-particularly 510(k) pathways-as well as extensive experience steering global teams, shaping regulatory policy, and influencing senior leadership.

Key Responsibilities

Regulatory Strategy & Leadership

• Develop, communicate, and implement a cohesive global regulatory strategy across all product lines, ensuring alignment with corporate objectives and long‑term growth plans.
• Serve as the executive regulatory representative in corporate planning, governance, and risk‑management forums.
• Shape regulatory policy positions and represent the company in industry associations, standards committees, and regulatory advocacy efforts.

Premarket Submissions & Approvals

• Provide strategic oversight and executive approval for all FDA 510(k) submissions, De Novos, PMAs, EU MDR Technical Documentation, and global registrations.
• Mentor teams in designing regulatory pathways that optimize time‑to‑market while ensuring robust safety and performance evidence.
• Build and sustain strong relationships with regulatory agencies, including FDA, notified bodies, and global regulators.

Labeling, Compliance & Postmarket

• Oversee the global product labeling strategy, ensuring compliance with FDA, EU MDR, and international standards.
• Lead regulatory activities supporting postmarket surveillance, vigilance reporting, product changes, and lifecycle management.
• Ensure organizational readiness for audits and inspections, including FDA inspections and notified body assessments.

Cross‑Functional Collaboration

• Advise executive leadership and cross‑functional partners-including R&D, Quality, Clinical, Operations, Marketing, and Legal-on regulatory requirements and risk.
• Integrate regulatory considerations into design controls, risk management, clinical evidence plans, and commercialization strategies.

Team Leadership & Organizational Development

• Lead, develop, and scale a high‑performing global regulatory organization.
• Establish departmental goals, KPIs, and operating mechanisms to ensure timely and compliant regulatory execution.
• Implement best‑practice regulatory systems, documentation processes, and standards to support compliance and growth.

Qualifications

• 15+ years of regulatory affairs experience in the medical device industry, including significant senior or executive leadership.
• Demonstrated success leading U.S. and international submissions, including multiple successful 510(k) filings.
• Deep expertise in FDA device regulations, EU MDR/IVDR, ISO 13485, and 21 CFR 820.
• Proven ability to influence senior leadership, drive complex cross‑functional initiatives, and manage regulatory risk.
• Exceptional communication, executive presence, and decision‑making capabilities.
• Strategic thinking paired with hands‑on knowledge of regulatory submissions and compliance requirements.