Neurology MedTech Regulatory VP — Strategy & Submissions

IQVIA; Washington (District of Columbia); On-site; USD 180,000 - 240,000; Full time

Job summary

IQVIA MedTech's MCRA division seeks a VP/Senior Director of Regulatory Affairs for Neurology MedTech. You will shape regulatory strategy, drive submissions across multiple therapies, and mentor a growing team while collaborating with clients and regulatory bodies.

The role involves leadership of complex projects and budgets, with direct interaction with executive management. Ideal candidates bring fifteen-plus years in Regulatory Affairs for medical devices and/or biologics, with neurology

Qualifications

• Bachelor's degree in a scientific, engineering, or regulatory discipline.
• MS or PhD preferred.
• Neurology medical device experience required; 15+ years in Regulatory Affairs.
• Experience in project management and managerial roles.

Responsibilities

• Develop and lead regulatory submissions (510(k), IDE, PMA, IND, BLA, etc.).
• Define and implement overall regulatory strategy and execution.
• Oversee pre-clinical testing design and review.
• Manage Regulatory Affairs staff and professional development.
• Lead business development efforts to secure new clients and projects.
• Develop project and departmental budgets and timelines; client communication.

Skills

Regulatory leadership

Regulatory submissions

Cross-functional leadership

Mentoring

Education

Bachelor's degree in science/engineering/regulatory

MS or PhD preferred

Job description

IQVIA MedTech's MCRA division seeks a VP/Senior Director of Regulatory Affairs for Neurology MedTech. You will shape regulatory strategy, drive submissions across multiple therapies, and mentor a growing team while collaborating with clients and regulatory bodies.

The role involves leadership of complex projects and budgets, with direct interaction with executive management. Ideal candidates bring fifteen-plus years in Regulatory Affairs for medical devices and/or biologics, with neurology