Director, Regulatory Affairs - Compliance Systems and Labeling

Overview
We are seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy, governance, and compliance for a diverse portfolio of medical devices. This role focuses on defining long‑term regulatory direction, ensuring organizational readiness for evolving global requirements, and maintaining robust systems that support compliant submissions and labeling. Hands‑on experience with FDA 510(k) pathways and global labeling requirements remains essential, though the emphasis is on leadership, oversight, and strategic influence.

Key Responsibilities

Regulatory Strategy & Leadership

• Develop and execute global regulatory strategies that support innovation, market expansion, and lifecycle management.
• Anticipate regulatory trends and emerging global requirements; create long‑range regulatory roadmaps and readiness plans.
• Partner with executive leadership to integrate regulatory considerations into business planning, portfolio decisions, and risk management.
• Provide strategic input during concept development, design controls, testing strategies, and clinical/validation planning.

Regulatory Compliance & Governance

• Oversee regulatory compliance programs aligned with FDA requirements, EU MDR, ISO 13485, and international expectations.
• Maintain regulatory systems, documentation, and processes in a state of audit readiness, including technical documentation, labeling governance, and change control.
• Lead or support regulatory inspections, notified body audits, and related remediation activities.
• Establish and maintain internal regulatory procedures, standards, and best practices.

Submissions & Labeling Oversight

• Provide strategic direction for regulatory submissions, including 510(k) premarket notifications, technical documentation, and global registrations.
• Review and approve regulatory content to ensure accuracy, consistency, and alignment with strategic goals.
• Oversee regulatory review and approval of product labeling, ensuring compliance with FDA, EU MDR, and global requirements.
• Mentor team members who prepare submissions and manage labeling components.

Team Development & Stakeholder Leadership

• Lead, coach, and develop a high‑performing regulatory affairs team.
• Build and maintain strong cross‑functional relationships to anticipate regulatory risks and support business objectives.
• Represent Regulatory Affairs in governance bodies, design review boards, and strategic planning forums.

Qualifications

• 12+ years of regulatory affairs experience in the medical device industry.
• Demonstrated success developing and implementing regulatory strategies across multiple product lines or technologies.
• Proven experience with FDA 510(k) submissions and global medical device documentation.
• Strong understanding of medical device labeling requirements and standards.
• Deep familiarity with global regulatory frameworks including 21 CFR 820, ISO 13485, EU MDR/IVDR.
• Experience leading regulatory compliance programs and supporting audits or inspections.
• Exceptional leadership, communication, and strategic decision‑making capabilities.