Sr. Specialist, Regulatory Affairs
MicroVentionAliso Viejo, California, United States
Posted January 23, 2026
91628 - 120263 USD
Full Time
About the Company
Terumo Neuro, formerly MicroVention, is a global leader in neurovascular medical technology that designs, develops, and commercializes innovative devices for the treatment of cerebral aneurysms, ischemic stroke, carotid artery disease, and neurovascular malformations. Since its founding in 1997 and acquisition by Terumo Corporation in 2006, the company has built a portfolio of more than 30 products that combine advanced engineering with clinical insight. Its distinctive approach blends rigorous research, a patient-centric focus, and a commitment to improving outcomes for complex neurovascular conditions. Terumo Neuro continues to drive progress in the field through cutting-edge solutions and collaborative partnerships with clinicians worldwide.
Job Description
Prepare strategy for worldwide product approval submission activities, ensure compliance to FDA and international regulatory agency requirements for Neurovascular and Peripheral devices, and act as sole representative from Regulatory to ensure regulatory compliance.
Requirements
- Bachelor's degree in a scientific or technical discipline or relevant field of study
- Minimum four (4) years of relevant professional regulatory experience
- Strong technical writing skills as evidenced by successful U.S. FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions, and/or the rest of the world (ROW) registrations