Associate Director Regulatory Affairs

Responsibilities

• Leading global regulatory strategy across the full product life-cycle
• Overseeing preparation and submission of major regulatory filings (510(k), IDE, PMA, EU MDR/CE mark, international registrations)
• Assessing regulatory risks, timelines, and trade-offs to inform business decisions
• Managing multiple concurrent regulatory programs with competing priorities
• Providing leadership, direction, and mentorship to regulatory managers and senior contributors
• Driving cross-functional alignment with R&D, clinical, quality, operations, and program teams
• Leading 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

Pay

TBD

Schedule

N/A

Benefits

N/A