VP/Senior Director, Neurology Regulatory Affairs

About the role

iqvia's MCRA (part of IQVIA MedTech) is looking for a VP/Senior Director, Regulatory Affairs - Neurology MedTech. The role supports regulatory strategy and submissions for client companies, manages regulatory submissions and strategy, communicates with regulatory bodies and clients, leads or expands new therapy ideas, manages personnel across projects and mentors junior employees. Projects may cover MCRA therapeutic areas, other MCRA areas of expertise and other growing therapeutic concentrations.

Key responsibilities

• Develop and execute regulatory services for clients, including submissions such as 510(k), IDE, PMA, IND, BLA, technical documentation, STED and CERs
• Develop regulatory strategy, analysis and development
• Design, review and implement pre-clinical testing
• Manage the regulatory affairs staff, facilitate professional development and ensure projects are completed accurately and on time
• Lead or manage business development to secure new clients and projects
• Develop project and departmental budgets and timelines
• Work directly with clients and regulatory bodies without oversight, maintaining a sole relationship with each client
• Collaborate with clinical, RHEMA and quality assurance teams, and with department heads and executives on the regulatory department's direction

Required profile

• Bachelor's degree in a scientific, engineering or regulatory discipline; MS or PhD preferred
• Neurology medical device experience required
• Minimum 15 years of regulatory affairs experience in medical devices, drugs and/or biologics, including project management and/or managerial experience
• US and/or international regulatory experience (FDA, Notified Body, ISO 13485)
• Understanding of clinical research and data analysis

Required skills

• Strong written and verbal communication and presentation skills, including medical/technical writing
• Attention to detail and ability to work independently and in multi-disciplinary teams
• Research, analytical, critical thinking and problem-solving skills
• Customer relations and client relationship management

The potential base pay range is $159,600 - $444,600 per year, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply.