Terumo Neuro · 12 hours ago
Sr. Specialist, Regulatory Affairs
Aliso Viejo, CA
Full-time
Onsite
Mid, Senior Level
$110K/yr - $120K/yr
4+ years expTerumo Neuro is a company focused on Neurovascular and Peripheral devices, and they are seeking a Sr. Specialist in Regulatory Affairs. The role involves preparing strategies for worldwide product approval submissions and ensuring compliance with FDA and international regulatory agency requirements.
Medical Device
Responsibilities
As a contributing member on product development and operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance
Depending on product/project complexity, develop or assist in developing regulatory strategy for assigned projects
Execute the approved global regulatory strategy for the assigned market(s)
Write multiple technical sections of the regulatory submission or complete submission
Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy
Document, consolidate, and maintain verbal and written communication with regulatory agencies
Maintain regulatory files and records
Review change order documents and assess regulatory impact of product changes on US, EU, Canada, and/or international regulatory strategy/submissions per MicroVention procedures
Review promotional material and labeling for regulatory compliance as assigned
Perform and/or oversee the technical publishing of submissions
Edit/revise Standard Operating Procedures (SOP) and Work Instructions (WI)
Build team cohesiveness by influencing and supporting team members
Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization
Perform additional responsibilities as assigned
Qualification
Required
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
Experience interfacing with regulatory authorities through various stages of device life cycle
Strong attention to detail
Strong written and verbal communication skills
Proficient computer skills, including MS Word, Excel, Outlook, and Teams
Preferred
Advanced degree in a scientific or technical discipline or relevant field of study
Experience in leading small to medium sized teams
Ability to work well in a team environment
Strong technical writing skills
Proven analytical abilities and organization skills
Ability to comprehend technical documents and concepts
Company
Terumo Neuro
We’re in business to create and deliver innovations that redefine what’s possible in neurovascular treatment, meaningfully advancing both physician practice and patient outcomes.
1001-5000 employees
H1B Sponsorship
Terumo Neuro has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (15)
2023 (7)
2022 (14)
2021 (8)
2020 (9)
Funding
Current Stage
Late StageCompany data provided by crunchbase