VP, Neurology Regulatory Affairs
Core
Lead regulatory strategy and submissions for neurology medical device clients, managing the full lifecycle from pre-clinical testing to commercialization.
Role type
VP, Regulatory Affairs (Neurology MedTech)
Builds
Regulatory submissions (510(k), IDE, PMA, IND, BLA), technical documentation, and strategic regulatory plans for medical device clients.
Domain
Medical Devices / Neurology / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, submission development, pre-clinical testing management, team leadership, business development, budget management, client relationship management, medical/technical writing, problem-solving
Preferred skills
MS or PhD, clinical research understanding, data analysis, engineering background, biological background
Technologies
FDA regulations, ISO 13485, Notified Body processes
Responsibilities
Develop and execute regulatory services including submissions and strategy; manage regulatory affairs staff and facilitate professional development; lead business development to secure new clients; manage project and departmental budgets; work directly with clients and regulatory bodies; collaborate with clinical, quality assurance, and executive teams.
Seniority
VP, strategic leadership & mentorship
