Associate Director Regulatory Affairs

About the role

The Associate Director of Regulatory Affairs will lead global regulatory strategy and execution for a rapidly expanding portfolio, providing senior regulatory leadership across new product development, clinical strategy, submissions, approvals, sustaining activities, and global expansion. The ideal candidate brings deep experience navigating complex regulatory pathways and managing high-impact programs in fast-paced environments.

Responsibilities

• Lead global regulatory strategy across the full product life-cycle
• Oversee preparation and submission of major regulatory filings, including 510(k), IDE, PMA, EU MDR/CE mark, and international registrations
• Assess regulatory risks, timelines, and trade-offs to inform business decisions
• Manage multiple concurrent regulatory programs with competing priorities
• Provide leadership, direction, and mentorship to regulatory managers and senior contributors
• Drive cross-functional alignment with R&D, clinical, quality, operations, and program teams
• Lead interactions with FDA, notified bodies, and other regulatory authorities

Qualifications

• Bachelor’s degree in a scientific, engineering, or related field
• 8+ years of regulatory affairs or closely related experience in the medical device industry
• 3+ years of people leadership experience, including managing managers or senior regulatory professionals
• Proven experience leading global regulatory strategy for complex device portfolios
• Extensive experience with 510(k), IDE, PMA, EU MDR/CE mark, and international submissions
• Strong communication, collaboration, and organizational skills
• Ability to operate effectively in complex, fast-moving, and ambiguous environments