Principal, Regulatory Affairs
MicroVentionAliso Viejo, California, United States
Posted December 3, 2025
119000 - 156000 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
Establish, prepare, and lead the strategy for worldwide product approval submission activities. Manage multiple large projects or processes and ensure compliance to FDA and international regulatory agency requirements.
Requirements
- Represent Regulatory on project teams and partner with cross functions
- Identify regulatory requirements for markets identified and develop global regulatory strategy
- Coach, review, and delegate work to junior regulatory affairs professionals
- Write, review, and file regulatory submissions
- Communicate with regulatory agencies
- Document and maintain verbal and written communication
- Review change order documents
- Review promotional material and labeling
- Develop and maintain regulatory files and records
- Support and contribute to developing, editing, or revising regulatory processes
- Lead training for global regulatory processes and system implementations
- Build team cohesiveness
Benefits
- Fair pay range: $119,000 - $156,000
- Potential for higher/lower financial compensation packages