Director, Regulatory Affairs - Neurology MedTech
$135,300–$376,800 year
On-site · Washington, District of Columbia, United States
Job Summary
Director, Regulatory Affairs - Neurology MedTech: Lead regulatory strategy and submissions for medical devices in neurology; manage regulatory deliverables (510(k), IDE, PMA, IND, BLA, CERs) and develop regulatory programs; supervise Regulatory Affairs staff, contribute to business development, and guide project budgets/timelines; collaborate with clinical, QA, RHEMA, and other departments; requires extensive neurology medical device experience, strong writing, and ability to communicate with regulatory bodies and clients; US/international regulatory expertise and governance of regulatory landscape are essential.
Required Qualifications
- Bachelor’s degree in a scientific, engineering, or regulatory discipline; MS or PhD preferred
- Neurology medical device experience required
- Minimum ten years of experience in Regulatory Affairs related to development of medical devices, drugs and/or biologics; including project management and/or managerial experience
- US and/or International regulatory experience/fluency with regulations (FDA, Notified Body, ISO 13485)
- Strong written, medical/technical writing, and verbal communication skills
- Ability to lead regulatory strategy, development of regulatory submissions (510(k), IDE, PMA, IND, BLA, STED, CERs) and design regulatory programs
- Experience mentoring/training junior staff and managing personnel
- Ability to work with cross-functional teams (clinical, QA, regulatory, engineering) and manage client relationships
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