Terumo Neuro · 17 hours ago
Principal, Regulatory Affairs
Aliso Viejo, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$120K/yr - $148K/yr
7+ years expTerumo Neuro is a company focused on Neurovascular and Peripheral devices, and they are seeking a Principal in Regulatory Affairs to lead worldwide product approval submission activities. The role involves managing large projects, ensuring compliance with regulatory requirements, and coaching junior professionals in the regulatory affairs team.
Medical Device
Responsibilities
Represent Regulatory on project teams and partner with the cross functions on the team to ensure alignment of global regulatory strategy with the team objectives
Identify regulatory requirements for the markets identified and work independently in developing global regulatory strategy for assigned projects and develop approaches to solutions
Coach, review, and delegate work to junior regulatory affairs professionals; may manage large projects and processes that span outside of immediate job area
Write, review, and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy
Communicate with regulatory agencies on administrative and routine matters
Document, consolidate, and maintain verbal and written communication with the regulatory agencies
Review change order documents and ascertain impact on current regulatory approvals
Review promotional material and labeling for regulatory compliance
Develop and maintain regulatory files and records
Support and contribute into developing, editing, or revising regulatory processes
Lead training for global regulatory processes and system implementations
Build team cohesiveness by influencing and mentoring 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 duties as assigned
Qualification
Required
Bachelor's degree in a scientific or technical discipline or relevant field of study
Minimum seven (7) to ten (10) years of professional regulatory experience
Ability to come into the office a minimum 3 days a week
Strong technical writing skills as evidence by multiple successful US FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions, and/or rest of the world (ROW) registrations across product lines
Prior direct involvement interfacing with regulatory authorities through regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review
Detail oriented
Strong written and verbal communication skills
Proficient computer skills, including MS Word, Excel, PowerPoint, Outlook, and Teams
Preferred
Advanced degree in a scientific or technical discipline or relevant field of study
Experience in leading large sized project teams across multiple product lines
Ability to work well in a team environment
Proven technical abilities; analytical 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