Director, Regulatory Affairs - Neurology MedTech
Core
Develop and execute regulatory strategy and submissions for neurology medical device clients, managing the lifecycle from concept to commercialization.
Role type
Director, Regulatory Affairs (Neurology MedTech)
Builds
Regulatory submissions (510(k), IDE, PMA, IND, BLA), technical documentation, and strategic regulatory plans for medical device companies.
Domain
Medical Device / Neurology / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy, submission development (510k, IDE, PMA, IND, BLA), project management, team leadership, business development, budget management, FDA/International regulatory fluency, medical/technical writing, pre-clinical testing oversight, stakeholder management
Preferred skills
MS or PhD, clinical research understanding, data analysis, engineering background, biological background
Technologies
FDA regulations, ISO 13485, Notified Body standards
Responsibilities
Manage regulatory submissions and strategy; lead business development to secure new clients; manage and mentor regulatory staff; develop project budgets and timelines; collaborate with clinical, quality, and executive teams.
Seniority
Director, strategic leadership & team management