Job Description

IQVIA MedTech seeks a VP/Senior Director for Regulatory Affairs in neurology to lead regulatory strategy, submissions, and client relationships for medical device and diagnostic companies. The role involves managing regulatory projects, personnel oversight, and cross-functional collaboration within a consulting environment.

Responsibilities

• Develop and execute regulatory submissions including 510(k), IDE, PMA, IND, BLA, and technical documentation
• Create regulatory strategy, analysis, and oversight of pre-clinical testing design and implementation
• Manage regulatory affairs staff, mentor junior employees, and ensure timely project completion
• Lead business development to secure new clients and manage direct client and regulatory body relationships
• Collaborate with clinical, quality assurance, and other departments to guide regulatory progress

Requirements

• Bachelor's degree in scientific, engineering, or regulatory discipline; MS or PhD preferred
• Minimum 15 years regulatory affairs experience in medical devices, drugs, or biologics
• Proven neurology medical device experience required
• Project management and managerial experience demonstrated
• FDA and international regulatory knowledge with clinical research understanding
• Strong medical/technical writing and presentation skills
• Engineering and biological background for pre-clinical and clinical strategy development

Compensation: $159,600–$444,600 base

Job Tags

Similar Jobs