Job Description

Location MV

Aliso Viejo, California, USA

Department Name

800-California Interventional Systems (CAIS)

Qualifications

1. Bachelor’s degree in a scientific or technical discipline or relevant field of study.
2. Minimum seven (7) to ten (10) years of professional regulatory experience.
3. 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.
4. 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.
5. Detail oriented.
6. Strong written and verbal communication skills.
7. Proficient computer skills, including MS Word, Excel, PowerPoint, Outlook, and Teams.

Desired Qualifications

1. Advanced degree in a scientific or technical discipline or relevant field of study.
2. Experience in leading large sized project teams across multiple product lines.
3. Ability to work well in a team environment.
4. Proven technical abilities; analytical and organization skills.
5. Ability to comprehend technical documents and concepts.

EEO
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)