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TE
Principal, Regulatory Affairs
Terumo NeuroAliso Viejo, United Statesfull_timeVerifiedPosted 3 Dec 2025
💰 $156,000/yr($119,000/yr – $156,000/yr)
About the role
Location MV
Aliso Viejo, California, USA
Department Name
800-California Interventional Systems (CAIS)
Qualifications
- 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.
- 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.
- 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.
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.
Fair Chance Ordinance
If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.
External-Facing Title
Principal, Regulatory Affairs
Posting Country
US - United States
Salary Range
$119,000 - $156,000 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)
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