VP/Senior Director, Neurology Regulatory Affairs (MedTech)

Location: Washington, DC, United States of America

Salary: $159,600–$444,600 annual base pay

Company

IQVIA MedTech and MCRA provide regulatory, clinical, market access, and post-market services for medical device and diagnostics companies within IQVIA's life sciences and healthcare business.

What you will do

• Develop and execute regulatory services, strategies, analyses, and submissions for client companies.
• Lead submissions including 510(k), IDE, PMA, IND, BLA, technical documentation, STED, and CERs.
• Design, review, and implement pre-clinical testing strategies.
• Manage regulatory affairs staff, support professional development, and mentor junior employees.
• Lead client relationships, regulatory-body communications, project delivery, budgets, timelines, and business development.
• Collaborate with clinical, RHEMA, quality assurance, department heads, and executive management.

Requirements

• Bachelor's degree in a scientific, engineering, or regulatory discipline; a master's degree or PhD is preferred.
• Neurology medical device experience is required.
• At least 15 years of regulatory affairs experience related to medical devices, drugs, and/or biologics, including regulatory deliverables and submissions.
• Project management and/or managerial experience.
• Understanding of clinical research, data analysis, engineering, biological science, and pre-clinical and clinical strategies.
• US and/or international regulatory experience, including FDA, Notified Body, and ISO 13485 requirements, plus strong technical writing, communication, analytical, and client-management skills.

Culture & Benefits

• Work across multidisciplinary regulatory, clinical, quality, and scientific teams.
• Lead projects directly with clients and regulatory bodies.
• Potential incentive plans, bonuses, and health and welfare benefits may be available in addition to base pay.
• Equal opportunity employment environment.